Senior Pharmacovigilance Manager

London, London Meet Life Sciences

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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.

Senior Pharmacovigilance Manager

London, London Meet Life Sciences

Posted today

Job Viewed

Tap Again To Close

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.

Senior Pharmacovigilance Manager

London, London Meet Life Sciences

Posted 8 days ago

Job Viewed

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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.

Pharmacovigilance Scientist Manager

Uxbridge, London Amgen

Posted today

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**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.
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Principal Pharmacovigilance Scientist

SW1A 0AA London, London £85000 Annually WhatJobs

Posted 22 days ago

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Job Description

full-time
Our client, a globally recognized pharmaceutical company at the forefront of medical innovation, is seeking a highly experienced Principal Pharmacovigilance Scientist to join their esteemed safety surveillance team. Based in London, England, UK , this role is instrumental in ensuring the safe and effective use of medicines by meticulously monitoring, evaluating, and reporting adverse events. The ideal candidate will possess deep expertise in pharmacovigilance regulations, signal detection, risk management, and regulatory reporting, combined with strong analytical and scientific writing skills. This position requires a commitment to patient safety and the ability to contribute significantly to the company's safety profile.

Key Responsibilities:
  • Lead the safety assessment of assigned pharmaceutical products, including signal detection, evaluation, and risk management planning.
  • Author and review aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and DSURs, for regulatory submissions.
  • Contribute to the development and implementation of pharmacovigilance strategies and processes.
  • Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure comprehensive safety surveillance.
  • Interpret safety data from clinical trials, post-marketing studies, and spontaneous reports.
  • Prepare safety information for Investigator Brochures, Informed Consent Forms, and other clinical trial documents.
  • Act as a subject matter expert on pharmacovigilance regulations and guidelines (e.g., FDA, EMA).
  • Respond to regulatory authority inquiries regarding product safety.
  • Mentor junior scientists and contribute to the development of the pharmacovigilance team.
  • Ensure compliance with all applicable pharmacovigilance regulations and company policies.
Qualifications:
  • Advanced degree (MSc, PhD, PharmD, MD) in a life science, pharmacy, medicine, or related field.
  • Minimum of 7-10 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
  • In-depth knowledge of global pharmacovigilance regulations and guidelines.
  • Proven experience in signal detection, risk assessment, and regulatory reporting.
  • Strong scientific writing and communication skills, with the ability to clearly articulate complex safety information.
  • Experience with safety databases and data analysis tools is essential.
  • Excellent analytical and critical thinking abilities.
  • Ability to work effectively in a hybrid environment, collaborating with colleagues both in the office and remotely.
  • Demonstrated leadership potential and the ability to influence decision-making.
This is a significant opportunity to contribute to patient safety at the highest level within a leading pharmaceutical organization. If you are passionate about drug safety and possess the requisite expertise, we encourage you to apply.
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