Pharmacovigilance jobs involve monitoring and evaluating the safety of pharmaceutical products. Professionals in this field play a crucial role in detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. These roles are vital for 25 Pharmacovigilance jobs in the United Kingdom
Pharmacovigilance Specialist
SR1 1BB Sunderland, North East
£45000 Annually
WhatJobs
Posted 16 days ago
Job Viewed
Job Description
Our client, a significant player in the pharmaceutical sector, is seeking a dedicated Pharmacovigilance Specialist to join their team in Sunderland, Tyne and Wear, UK . This role is crucial for ensuring the safety of their medicinal products through the effective monitoring and reporting of adverse events. You will be responsible for the intake, assessment, and documentation of adverse event reports from various sources, including healthcare professionals, patients, and clinical trials. A key aspect of this role involves ensuring compliance with global regulatory requirements for pharmacovigilance, including ICSR reporting. The ideal candidate will possess a strong understanding of drug safety principles, regulatory guidelines (e.g., GVP), and database management. You will collaborate with internal departments such as Regulatory Affairs, Medical Affairs, and Clinical Operations, as well as external partners. This position requires meticulous attention to detail, excellent organisational skills, and the ability to manage multiple tasks efficiently. You will contribute to risk management activities and assist in the preparation of safety reports. This is an excellent opportunity for a motivated professional to advance their career in drug safety within a supportive and growing company.
Responsibilities:
Responsibilities:
- Receive, assess, and document adverse event reports in accordance with company procedures and regulatory requirements.
- Ensure timely and accurate submission of Individual Case Safety Reports (ICSRs) to regulatory authorities.
- Perform case processing, including data entry, query management, and medical coding.
- Liaise with internal departments and external stakeholders to obtain necessary information for case processing.
- Contribute to the preparation of periodic safety update reports (PSURs, PBRERs).
- Assist in the development and maintenance of pharmacovigilance procedures and training materials.
- Participate in audits and inspections related to pharmacovigilance.
- Monitor and interpret regulatory intelligence related to drug safety.
- Contribute to signal detection and risk management activities.
- Degree in a life science, nursing, pharmacy, or related healthcare field.
- Minimum of 2-3 years of experience in pharmacovigilance or drug safety.
- Knowledge of ICH-GCP, GVP, and other relevant regulatory guidelines.
- Experience with pharmacovigilance databases and case processing software.
- Excellent understanding of adverse event reporting requirements in major markets.
- Strong analytical, organisational, and problem-solving skills.
- Meticulous attention to detail and accuracy.
- Effective written and verbal communication skills.
- Ability to work effectively in a team environment and manage time efficiently.
This advertiser has chosen not to accept applicants from your region.
0
Senior Pharmacovigilance Manager
London, London
Meet Life Sciences
Posted today
Job Viewed
Job Description
Working With Us Challenging. Meaningful. Life-changing. Those aren’t words usually associated with a job — but this opportunity is anything but ordinary. Here, uniquely interesting work happens every day, across every department. From advancing production processes to pioneering scientific breakthroughs, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. We recognize the importance of balance and flexibility in the workplace. That’s why we offer a variety of competitive benefits, services, and programs to support employees in achieving their goals — both professionally and personally. Position Purpose In this role, you will collaborate with global process leads and process owners within Patient Safety to help develop a quality and compliance framework that ensures processes remain robust and inspection-ready. You will provide oversight of pharmacovigilance (PV) processes through monitoring, analysis, and continuous improvement, ensuring alignment with GVP guidelines, regulatory expectations, and industry best practices. Responsibilities Quality & Compliance Oversight Develop and execute quality and compliance monitoring activities for Patient Safety processes. Ensure a strong and compliant GVP Quality Management System is in place. Data Collation & Analysis Gather and analyse data from multiple stakeholders, identifying trends and system health indicators. Provide insights that support proactive risk mitigation and process improvement. Reporting & Visualization Create clear, actionable reports and dashboards for stakeholders. Translate complex data into meaningful insights to guide decision-making. Collaboration & Communication Work closely with functional leads, process owners, and senior leaders to drive continuous quality improvement. Share findings and reinforce process expectations through regular communication. Strategy & Process Improvement Evaluate effectiveness of quality monitoring programs, recommending updates as needed. Partner with stakeholders to enhance processes and overall system efficiency. Stakeholder Management Ensure effective oversight of internal and outsourced PV activities. Escalate compliance concerns and coordinate remediation actions when required. Inspections & Audits Support inspection and audit preparation, execution, and follow-up. Collaborate with Quality Assurance teams to implement continuous improvements. Tools & Intelligence Define business requirements for compliance-related tools and partner with IT to deliver enhancements. Contribute to development of data-driven solutions that provide holistic oversight of PV systems. Key Competencies Critical and strategic thinking, with the ability to evaluate evidence and form sound judgments. Strong data management and analysis skills, with an eye for identifying trends and anomalies. Effective decision-making using data summaries and clear guidelines. Proficiency with digital and visualization tools (e.g., Tableau, Power BI); experience with AI/ML approaches is a plus. Qualifications & Experience Degree in Life Sciences, Pharmacy, Nursing, or a related field. 8 years of pharmaceutical industry experience, including pharmacovigilance, clinical development, drug development, or regulatory affairs. Deep knowledge of global PV regulations and compliance requirements. Proven ability to analyze complex datasets and translate findings into actionable insights. Experience in quality and compliance roles within PV or drug safety. Track record of advising senior management on regulatory/compliance matters. Ability to navigate complex environments and drive accountability. Why Join Us? This is a unique opportunity to play a key role in advancing patient safety and shaping the future of pharmacovigilance. You will work in a dynamic, collaborative environment where your contributions directly impact patients’ lives — while developing your own career in meaningful new ways. Location: Hybrid role, based in either the wider London area (UK) or in Nordics (Sweden, Norway, Denmark or Finland).
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmacovigilance Manager
London, London
Meet Life Sciences
Posted today
Job Viewed
Job Description
Working With Us Challenging. Meaningful. Life-changing. Those aren’t words usually associated with a job — but this opportunity is anything but ordinary. Here, uniquely interesting work happens every day, across every department. From advancing production processes to pioneering scientific breakthroughs, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. We recognize the importance of balance and flexibility in the workplace. That’s why we offer a variety of competitive benefits, services, and programs to support employees in achieving their goals — both professionally and personally. Position Purpose In this role, you will collaborate with global process leads and process owners within Patient Safety to help develop a quality and compliance framework that ensures processes remain robust and inspection-ready. You will provide oversight of pharmacovigilance (PV) processes through monitoring, analysis, and continuous improvement, ensuring alignment with GVP guidelines, regulatory expectations, and industry best practices. Responsibilities Quality & Compliance Oversight Develop and execute quality and compliance monitoring activities for Patient Safety processes. Ensure a strong and compliant GVP Quality Management System is in place. Data Collation & Analysis Gather and analyse data from multiple stakeholders, identifying trends and system health indicators. Provide insights that support proactive risk mitigation and process improvement. Reporting & Visualization Create clear, actionable reports and dashboards for stakeholders. Translate complex data into meaningful insights to guide decision-making. Collaboration & Communication Work closely with functional leads, process owners, and senior leaders to drive continuous quality improvement. Share findings and reinforce process expectations through regular communication. Strategy & Process Improvement Evaluate effectiveness of quality monitoring programs, recommending updates as needed. Partner with stakeholders to enhance processes and overall system efficiency. Stakeholder Management Ensure effective oversight of internal and outsourced PV activities. Escalate compliance concerns and coordinate remediation actions when required. Inspections & Audits Support inspection and audit preparation, execution, and follow-up. Collaborate with Quality Assurance teams to implement continuous improvements. Tools & Intelligence Define business requirements for compliance-related tools and partner with IT to deliver enhancements. Contribute to development of data-driven solutions that provide holistic oversight of PV systems. Key Competencies Critical and strategic thinking, with the ability to evaluate evidence and form sound judgments. Strong data management and analysis skills, with an eye for identifying trends and anomalies. Effective decision-making using data summaries and clear guidelines. Proficiency with digital and visualization tools (e.g., Tableau, Power BI); experience with AI/ML approaches is a plus. Qualifications & Experience Degree in Life Sciences, Pharmacy, Nursing, or a related field. 8 years of pharmaceutical industry experience, including pharmacovigilance, clinical development, drug development, or regulatory affairs. Deep knowledge of global PV regulations and compliance requirements. Proven ability to analyze complex datasets and translate findings into actionable insights. Experience in quality and compliance roles within PV or drug safety. Track record of advising senior management on regulatory/compliance matters. Ability to navigate complex environments and drive accountability. Why Join Us? This is a unique opportunity to play a key role in advancing patient safety and shaping the future of pharmacovigilance. You will work in a dynamic, collaborative environment where your contributions directly impact patients’ lives — while developing your own career in meaningful new ways. Location: Hybrid role, based in either the wider London area (UK) or in Nordics (Sweden, Norway, Denmark or Finland).
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmacovigilance Manager
London, London
Meet Life Sciences
Posted 8 days ago
Job Viewed
Job Description
Working With Us
Challenging. Meaningful. Life-changing. Those aren’t words usually associated with a job — but this opportunity is anything but ordinary. Here, uniquely interesting work happens every day, across every department. From advancing production processes to pioneering scientific breakthroughs, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.
We recognize the importance of balance and flexibility in the workplace. That’s why we offer a variety of competitive benefits, services, and programs to support employees in achieving their goals — both professionally and personally.
Position Purpose
In this role, you will collaborate with global process leads and process owners within Patient Safety to help develop a quality and compliance framework that ensures processes remain robust and inspection-ready. You will provide oversight of pharmacovigilance (PV) processes through monitoring, analysis, and continuous improvement, ensuring alignment with GVP guidelines, regulatory expectations, and industry best practices.
Responsibilities
Quality & Compliance Oversight
- Develop and execute quality and compliance monitoring activities for Patient Safety processes.
- Ensure a strong and compliant GVP Quality Management System is in place.
Data Collation & Analysis
- Gather and analyse data from multiple stakeholders, identifying trends and system health indicators.
- Provide insights that support proactive risk mitigation and process improvement.
Reporting & Visualization
- Create clear, actionable reports and dashboards for stakeholders.
- Translate complex data into meaningful insights to guide decision-making.
Collaboration & Communication
- Work closely with functional leads, process owners, and senior leaders to drive continuous quality improvement.
- Share findings and reinforce process expectations through regular communication.
Strategy & Process Improvement
- Evaluate effectiveness of quality monitoring programs, recommending updates as needed.
- Partner with stakeholders to enhance processes and overall system efficiency.
Stakeholder Management
- Ensure effective oversight of internal and outsourced PV activities.
- Escalate compliance concerns and coordinate remediation actions when required.
Inspections & Audits
- Support inspection and audit preparation, execution, and follow-up.
- Collaborate with Quality Assurance teams to implement continuous improvements.
Tools & Intelligence
- Define business requirements for compliance-related tools and partner with IT to deliver enhancements.
- Contribute to development of data-driven solutions that provide holistic oversight of PV systems.
Key Competencies
- Critical and strategic thinking, with the ability to evaluate evidence and form sound judgments.
- Strong data management and analysis skills, with an eye for identifying trends and anomalies.
- Effective decision-making using data summaries and clear guidelines.
- Proficiency with digital and visualization tools (e.g., Tableau, Power BI); experience with AI/ML approaches is a plus.
Qualifications & Experience
- Degree in Life Sciences, Pharmacy, Nursing, or a related field.
- 8+ years of pharmaceutical industry experience, including pharmacovigilance, clinical development, drug development, or regulatory affairs.
- Deep knowledge of global PV regulations and compliance requirements.
- Proven ability to analyze complex datasets and translate findings into actionable insights.
- Experience in quality and compliance roles within PV or drug safety.
- Track record of advising senior management on regulatory/compliance matters.
- Ability to navigate complex environments and drive accountability.
Why Join Us?
This is a unique opportunity to play a key role in advancing patient safety and shaping the future of pharmacovigilance. You will work in a dynamic, collaborative environment where your contributions directly impact patients’ lives — while developing your own career in meaningful new ways.
Location: Hybrid role, based in either the wider London area (UK) or in Nordics (Sweden, Norway, Denmark or Finland).
This advertiser has chosen not to accept applicants from your region.
3
Senior Pharmacovigilance Manager
Meet Life Sciences
Posted 9 days ago
Job Viewed
Job Description
Working With Us
Challenging. Meaningful. Life-changing. Those aren’t words usually associated with a job — but this opportunity is anything but ordinary. Here, uniquely interesting work happens every day, across every department. From advancing production processes to pioneering scientific breakthroughs, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.
We recognize the importance of balance and flexibility in the workplace. That’s why we offer a variety of competitive benefits, services, and programs to support employees in achieving their goals — both professionally and personally.
Position Purpose
In this role, you will collaborate with global process leads and process owners within Patient Safety to help develop a quality and compliance framework that ensures processes remain robust and inspection-ready. You will provide oversight of pharmacovigilance (PV) processes through monitoring, analysis, and continuous improvement, ensuring alignment with GVP guidelines, regulatory expectations, and industry best practices.
Responsibilities
Quality & Compliance Oversight
- Develop and execute quality and compliance monitoring activities for Patient Safety processes.
- Ensure a strong and compliant GVP Quality Management System is in place.
Data Collation & Analysis
- Gather and analyse data from multiple stakeholders, identifying trends and system health indicators.
- Provide insights that support proactive risk mitigation and process improvement.
Reporting & Visualization
- Create clear, actionable reports and dashboards for stakeholders.
- Translate complex data into meaningful insights to guide decision-making.
Collaboration & Communication
- Work closely with functional leads, process owners, and senior leaders to drive continuous quality improvement.
- Share findings and reinforce process expectations through regular communication.
Strategy & Process Improvement
- Evaluate effectiveness of quality monitoring programs, recommending updates as needed.
- Partner with stakeholders to enhance processes and overall system efficiency.
Stakeholder Management
- Ensure effective oversight of internal and outsourced PV activities.
- Escalate compliance concerns and coordinate remediation actions when required.
Inspections & Audits
- Support inspection and audit preparation, execution, and follow-up.
- Collaborate with Quality Assurance teams to implement continuous improvements.
Tools & Intelligence
- Define business requirements for compliance-related tools and partner with IT to deliver enhancements.
- Contribute to development of data-driven solutions that provide holistic oversight of PV systems.
Key Competencies
- Critical and strategic thinking, with the ability to evaluate evidence and form sound judgments.
- Strong data management and analysis skills, with an eye for identifying trends and anomalies.
- Effective decision-making using data summaries and clear guidelines.
- Proficiency with digital and visualization tools (e.g., Tableau, Power BI); experience with AI/ML approaches is a plus.
Qualifications & Experience
- Degree in Life Sciences, Pharmacy, Nursing, or a related field.
- 8+ years of pharmaceutical industry experience, including pharmacovigilance, clinical development, drug development, or regulatory affairs.
- Deep knowledge of global PV regulations and compliance requirements.
- Proven ability to analyze complex datasets and translate findings into actionable insights.
- Experience in quality and compliance roles within PV or drug safety.
- Track record of advising senior management on regulatory/compliance matters.
- Ability to navigate complex environments and drive accountability.
Why Join Us?
This is a unique opportunity to play a key role in advancing patient safety and shaping the future of pharmacovigilance. You will work in a dynamic, collaborative environment where your contributions directly impact patients’ lives — while developing your own career in meaningful new ways.
Location: Hybrid role, based in either the wider London area (UK) or in Nordics (Sweden, Norway, Denmark or Finland).
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmacovigilance Associate
Reading, South East
ICON Clinical Research
Posted today
Job Viewed
Job Description
Senior Pharmacovigilance Associate
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.
**What You Will Be Doing:**
+ Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
+ Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
+ Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
+ Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
+ Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
+ Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
+ Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
+ Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.
**Your Profile:**
+ Bachelor's degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.
+ Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
+ Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
+ Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
+ Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
+ Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
+ Ability to work independently and manage multiple priorities in a fast-paced environment.
+ Commitment to maintaining confidentiality and handling sensitive patient information with discretion.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.
**What You Will Be Doing:**
+ Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
+ Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
+ Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
+ Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
+ Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
+ Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
+ Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
+ Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.
**Your Profile:**
+ Bachelor's degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.
+ Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
+ Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
+ Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
+ Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
+ Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
+ Ability to work independently and manage multiple priorities in a fast-paced environment.
+ Commitment to maintaining confidentiality and handling sensitive patient information with discretion.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.
5
Pharmacovigilance Scientist Manager
Uxbridge, London
Amgen
Posted today
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**PHARMACOVIGILANCE SCIENTIST MANAGER**
**What you will do**
**In this vital role the Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.**
+ Contribute to the planning, preparation, writing and review of non-medical portions of aggregate reports
+ Work with affiliates and other internal Amgen partners regarding deliverables
+ Review of AE/SAEs from clinical trials as needed
+ Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
+ Review standard design of tables, figures, and listings for safety data from clinical studies
+ Participate in development of safety-related data collection forms for clinical studies
+ Attend study team meetings as requested or needed
+ Conduct signal detection, evaluation, and management
+ Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
+ Prepare safety assessment reports and other safety documents and regulatory responses
+ Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
+ Participates in Safety Governance per Amgen processes
+ Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
+ Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
+ Provide contents for risk management plans
+ Update strategy and content for regional risk management plans
+ Assist GSOs to coordinate risk minimization activities including tracking of activities as needed
+ Evaluate risk minimization activity
+ Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
+ Support activities related to new drug applications and other regulatory filings
+ Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
+ Provide safety contents for filings
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications.
+ Degree educated with directly relevant Global Patient Safety experience
+ Clinical/medical research experience
+ Experience in a biotech/pharmaceutical setting
+ Strong technical competency
+ Strong attention to detail and time management
+ Strong written communication
+ Strong planning and problem solving skills
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote setting may be considered
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**PHARMACOVIGILANCE SCIENTIST MANAGER**
**What you will do**
**In this vital role the Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.**
+ Contribute to the planning, preparation, writing and review of non-medical portions of aggregate reports
+ Work with affiliates and other internal Amgen partners regarding deliverables
+ Review of AE/SAEs from clinical trials as needed
+ Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
+ Review standard design of tables, figures, and listings for safety data from clinical studies
+ Participate in development of safety-related data collection forms for clinical studies
+ Attend study team meetings as requested or needed
+ Conduct signal detection, evaluation, and management
+ Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
+ Prepare safety assessment reports and other safety documents and regulatory responses
+ Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
+ Participates in Safety Governance per Amgen processes
+ Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
+ Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
+ Provide contents for risk management plans
+ Update strategy and content for regional risk management plans
+ Assist GSOs to coordinate risk minimization activities including tracking of activities as needed
+ Evaluate risk minimization activity
+ Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
+ Support activities related to new drug applications and other regulatory filings
+ Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
+ Provide safety contents for filings
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications.
+ Degree educated with directly relevant Global Patient Safety experience
+ Clinical/medical research experience
+ Experience in a biotech/pharmaceutical setting
+ Strong technical competency
+ Strong attention to detail and time management
+ Strong written communication
+ Strong planning and problem solving skills
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote setting may be considered
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Pharmacovigilance Jobs in United Kingdom !
6
Pharmacovigilance Compliance Leader
Chalfont St Giles, South East
GE HealthCare
Posted 13 days ago
Job Viewed
Job Description
**Job Description Summary**
We are seeking a highly motivated and detail-oriented PV Compliance Leader to strengthen our global Pharmacovigilance Quality Team (PV-QA).
The PV Compliance Leader plays a critical role in ensuring the integrity and compliance of the Global Pharmacovigilance (PV) system. This role supports the development and maintenance of PV quality documentation, drives audit and inspection readiness, and leads the resolution of compliance findings. The ideal candidate is passionate about driving compliance and continuous improvement, and has a strong understanding of Good Vigilance Practices, a proactive mindset, and the ability to collaborate across global functions.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world
**Job Description**
**Description**
The PV/QA team serves as a strategic bridge between the Quality Assurance (QA) and Global Pharmacovigilance (PV) organizations, fostering a culture of compliance and continuous improvement. PV-QA are accountable for ensuring PV compliance with regulatory obligations and the GEHC PDx Quality Management System across the global PV network, through the following activities:
+ Maintain and continually improve a suite of lean PV operating procedures that can be consistently applied across the organisation
+ Design and implement supporting PV training and awareness initiatives
+ Continuous monitoring of the effectiveness of the QMS through deviation management, audit outcome, KPI reporting, management review, and authority inspection support to drive strategic improvement.
**Responsibilities**
**SOP and Quality Document Management** : Draft, review, and maintain standard operating procedures (SOPs), work instructions, and related PV quality documentation to ensure alignment with regulatory requirements and internal QMS standards.
**Audit and Inspection Support:** Prepare for internal and external audits and regulatory inspections by coordinating documentation, training, and readiness activities. Act as a point of contact during inspections and support follow-up actions.
**CAPA and Deviation Management:** Lead or support root cause investigations for audit findings, deviations, and non-compliance issues. Develop and implement corrective and preventive action (CAPA) plans and track their effectiveness.
**Compliance Monitoring:** Monitor compliance metrics and KPIs across the PV system. Identify trends and areas for improvement and contribute to continuous quality improvement initiatives.
**Stakeholder Collaboration:** Work closely with cross-functional teams including Quality Assurance, Regulatory Affairs, Medical Affairs, and Local Safety Units to ensure consistent application of PV standards and practices.
**Training and Awareness:** Support the development and delivery of PV training programs and awareness initiatives across the Global PV Network and PDx organization.
**Qualifications**
+ Academic degree in life sciences; **pharmacy or nursing preferred**
+ Significant **experience** in Pharmacovigilance, Quality, or Regulatory activities within the **Pharma/Life Sciences industry**
+ Strong knowledge of GvP and global PV regulatory requirements
+ Proven experience in SOP writing, audit/inspection preparation, and CAPA management
+ Working knowledge of Safety and Deviation management databases
+ Exposure to working relationship with FDA, EMA and other regulatory authorities is an asset
+ Fluent in **English** (written and spoken); proficiency in other languages is an asset
+ Proficient in **Microsoft Office** , with **strong Excel skills**
**Desired Skills**
+ Self-motivated with the ability to **prioritize, schedule, and organize** daily activities
+ Excellent **communication and interpersonal skills** : ability to communicate across organization levels and to connect with different audiences in a multicultural environment
+ Ability to work with **interdisciplinary, highly matrixed teams** and able to communicate complex messages. Good negotiating and influencing skills
+ Strong **commitment to compliance** with relevant regulations and procedures
+ Ability to **set priorities and pivot** as needed in a dynamic environment, ability to recognize **time sensitivity**
+ High **integrity, flexibility** , and willingness to **travel occasionally**
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-MG1
**Additional Information**
**Relocation Assistance Provided:** No
We are seeking a highly motivated and detail-oriented PV Compliance Leader to strengthen our global Pharmacovigilance Quality Team (PV-QA).
The PV Compliance Leader plays a critical role in ensuring the integrity and compliance of the Global Pharmacovigilance (PV) system. This role supports the development and maintenance of PV quality documentation, drives audit and inspection readiness, and leads the resolution of compliance findings. The ideal candidate is passionate about driving compliance and continuous improvement, and has a strong understanding of Good Vigilance Practices, a proactive mindset, and the ability to collaborate across global functions.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world
**Job Description**
**Description**
The PV/QA team serves as a strategic bridge between the Quality Assurance (QA) and Global Pharmacovigilance (PV) organizations, fostering a culture of compliance and continuous improvement. PV-QA are accountable for ensuring PV compliance with regulatory obligations and the GEHC PDx Quality Management System across the global PV network, through the following activities:
+ Maintain and continually improve a suite of lean PV operating procedures that can be consistently applied across the organisation
+ Design and implement supporting PV training and awareness initiatives
+ Continuous monitoring of the effectiveness of the QMS through deviation management, audit outcome, KPI reporting, management review, and authority inspection support to drive strategic improvement.
**Responsibilities**
**SOP and Quality Document Management** : Draft, review, and maintain standard operating procedures (SOPs), work instructions, and related PV quality documentation to ensure alignment with regulatory requirements and internal QMS standards.
**Audit and Inspection Support:** Prepare for internal and external audits and regulatory inspections by coordinating documentation, training, and readiness activities. Act as a point of contact during inspections and support follow-up actions.
**CAPA and Deviation Management:** Lead or support root cause investigations for audit findings, deviations, and non-compliance issues. Develop and implement corrective and preventive action (CAPA) plans and track their effectiveness.
**Compliance Monitoring:** Monitor compliance metrics and KPIs across the PV system. Identify trends and areas for improvement and contribute to continuous quality improvement initiatives.
**Stakeholder Collaboration:** Work closely with cross-functional teams including Quality Assurance, Regulatory Affairs, Medical Affairs, and Local Safety Units to ensure consistent application of PV standards and practices.
**Training and Awareness:** Support the development and delivery of PV training programs and awareness initiatives across the Global PV Network and PDx organization.
**Qualifications**
+ Academic degree in life sciences; **pharmacy or nursing preferred**
+ Significant **experience** in Pharmacovigilance, Quality, or Regulatory activities within the **Pharma/Life Sciences industry**
+ Strong knowledge of GvP and global PV regulatory requirements
+ Proven experience in SOP writing, audit/inspection preparation, and CAPA management
+ Working knowledge of Safety and Deviation management databases
+ Exposure to working relationship with FDA, EMA and other regulatory authorities is an asset
+ Fluent in **English** (written and spoken); proficiency in other languages is an asset
+ Proficient in **Microsoft Office** , with **strong Excel skills**
**Desired Skills**
+ Self-motivated with the ability to **prioritize, schedule, and organize** daily activities
+ Excellent **communication and interpersonal skills** : ability to communicate across organization levels and to connect with different audiences in a multicultural environment
+ Ability to work with **interdisciplinary, highly matrixed teams** and able to communicate complex messages. Good negotiating and influencing skills
+ Strong **commitment to compliance** with relevant regulations and procedures
+ Ability to **set priorities and pivot** as needed in a dynamic environment, ability to recognize **time sensitivity**
+ High **integrity, flexibility** , and willingness to **travel occasionally**
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-MG1
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmacovigilance Specialist
NE2 1TL Newcastle upon Tyne, North East
£58000 Annually
WhatJobs
Posted 2 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company committed to patient safety, is seeking a meticulous and experienced Senior Pharmacovigilance Specialist to join their dedicated safety monitoring team. This role is integral to ensuring the safe and effective use of medicinal products throughout their lifecycle. You will be responsible for the collection, assessment, and reporting of adverse event data, ensuring compliance with global regulatory requirements. Key duties include evaluating case reports, determining causality, and preparing regulatory safety submissions. A thorough understanding of pharmacovigilance regulations (e.g., GVP modules) and safety databases (e.g., Argus, ArisG) is essential. You will collaborate closely with internal departments, including clinical operations, medical affairs, and regulatory affairs, as well as external stakeholders such as healthcare professionals and regulatory authorities. The ideal candidate will possess exceptional analytical and critical thinking skills, meticulous attention to detail, and strong written and verbal communication abilities. Experience in signal detection and risk management activities is highly desirable. This position requires a proactive approach to problem-solving and a commitment to maintaining the highest standards of patient safety. You will contribute to the ongoing assessment of product safety profiles and support risk mitigation strategies. A Bachelor's or Master's degree in a life sciences, nursing, pharmacy, or related field, along with a minimum of 5 years of experience in pharmacovigilance, is required. This role operates on a hybrid basis, offering a blend of remote work flexibility and in-office collaboration at their prestigious Newcastle upon Tyne, Tyne and Wear, UK location.
This advertiser has chosen not to accept applicants from your region.
8
Principal Pharmacovigilance Scientist
BS1 4SX Bristol, South West
£65000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking an accomplished Principal Pharmacovigilance Scientist to join their cutting-edge research and development team in **Bristol, South West England, UK**. This pivotal role offers a hybrid working model, combining the benefits of remote work with essential in-person collaboration. You will be at the forefront of ensuring the safety of our pharmaceutical products, meticulously monitoring and evaluating adverse event data. Your expertise will be crucial in identifying potential safety signals, conducting in-depth signal detection and assessment, and contributing to robust risk management plans. This role demands a deep understanding of regulatory requirements across major global markets, including the EU, US, and beyond. You will play a key role in authoring and reviewing safety reports, such as Periodic Benefit Risk Evaluations (PBRERs) and Development Safety Update Reports (DSURs), ensuring accuracy, completeness, and adherence to stringent timelines. Collaboration is paramount; you will work closely with clinical development, regulatory affairs, medical affairs, and other cross-functional teams to integrate safety information into product lifecycle management. Furthermore, you will contribute to the development and implementation of pharmacovigilance strategies, standard operating procedures (SOPs), and training materials. The ideal candidate possesses exceptional analytical skills, a meticulous attention to detail, and a strong scientific and medical background. You will be adept at interpreting complex data sets, making informed scientific judgments, and communicating findings effectively to diverse audiences, including senior management and regulatory authorities. This position offers a unique opportunity to shape the safety profile of innovative therapeutics and contribute to patient well-being.
Key Responsibilities:
Key Responsibilities:
- Lead the detection, assessment, and management of safety signals for assigned products.
- Author and review regulatory safety reports (e.g., PBRERs, DSURs, IND/NDA safety updates).
- Contribute to the development and execution of pharmacovigilance strategies and plans.
- Collaborate with cross-functional teams to ensure integrated safety assessments.
- Interpret and apply global pharmacovigilance regulations and guidelines.
- Develop and update pharmacovigilance SOPs and training materials.
- Provide expert input into risk management plans and benefit-risk assessments.
- Participate in regulatory agency interactions regarding product safety.
- Mentor junior members of the pharmacovigilance team.
- Advanced degree (MSc, PhD, MD, PharmD) in a life science or medical field.
- Significant experience in pharmacovigilance and drug safety.
- Proven expertise in signal detection, risk management, and regulatory reporting.
- Thorough knowledge of global regulatory requirements for pharmacovigilance.
- Excellent analytical, written, and verbal communication skills.
- Ability to manage multiple projects and deadlines in a complex environment.
- Experience with safety databases and pharmacovigilance software.
- Strong understanding of clinical trial processes and pharmaceutical development.
This advertiser has chosen not to accept applicants from your region.
9