13 Senior Pharmacovigilance Scientist jobs in the United Kingdom
Principal Pharmacovigilance Scientist
Posted 7 days ago
Job Viewed
Job Description
In this comprehensive role, you will be instrumental in establishing and maintaining robust pharmacovigilance systems. Your responsibilities will encompass the detailed assessment of adverse event reports, signal detection and evaluation, risk management plan development, and ensuring regulatory compliance with global safety guidelines. You will work closely with regulatory affairs, clinical operations, and medical affairs teams to provide expert safety insights and recommendations. This position offers a unique opportunity to shape safety strategies and contribute to the global drug safety profile of our pipeline and marketed products.
Key responsibilities include:
- Leading the safety assessment of assigned pharmaceutical products.
- Developing and implementing pharmacovigilance strategies and risk management plans.
- Performing signal detection activities and conducting in-depth benefit-risk assessments.
- Authoring and reviewing aggregate safety reports (e.g., DSURs, PBRERs).
- Ensuring compliance with global regulatory requirements for pharmacovigilance.
- Collaborating with internal and external stakeholders on safety-related matters.
- Providing training and guidance to other team members on pharmacovigilance principles.
- Contributing to the development of departmental policies and procedures.
- Managing and mentoring junior scientists within the pharmacovigilance team.
The ideal candidate will hold a PharmD, PhD, MD, or equivalent advanced degree in a life science discipline. A minimum of 8-10 years of experience in pharmacovigilance within the pharmaceutical industry is required. Proven expertise in signal detection, risk management, regulatory submissions, and international safety regulations is essential. Exceptional analytical, critical thinking, and communication skills are necessary, along with the ability to thrive in a fully remote, collaborative environment. Experience with various safety databases and reporting tools is also expected.
Senior Pharmacovigilance Scientist
Posted 9 days ago
Job Viewed
Job Description
Key Responsibilities:
- Monitor, collect, and evaluate adverse event data from various sources, including clinical trials, post-marketing surveillance, and literature.
- Conduct signal detection and risk assessment activities to identify potential safety issues associated with pharmaceutical products.
- Prepare and review aggregate safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Contribute to the development and maintenance of Risk Management Plans (RMPs).
- Collaborate with internal departments (e.g., Clinical Development, Regulatory Affairs, Medical Affairs) and external partners to ensure comprehensive safety assessments.
- Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, MHRA).
- Manage and interpret safety databases, utilizing analytical tools to identify trends and patterns.
- Author safety narratives and contribute to regulatory submissions related to product safety.
- Provide pharmacovigilance expertise and training to relevant stakeholders.
- Participate in safety review meetings and contribute to risk-benefit assessments.
- Stay current with emerging safety issues, scientific literature, and regulatory changes in pharmacovigilance.
- Respond to safety queries from regulatory authorities and internal teams.
- Advanced degree (MSc, PhD, PharmD) in a relevant scientific or medical field (e.g., Pharmacy, Toxicology, Life Sciences, Medicine).
- Minimum of 5-7 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry.
- Strong knowledge of global pharmacovigilance regulations and guidelines.
- Proven experience in adverse event data collection, analysis, and signal detection.
- Proficiency in safety databases (e.g., Argus Safety, ARISg) and data analysis tools.
- Excellent scientific writing skills, with the ability to prepare clear and concise safety reports.
- Strong analytical and critical thinking abilities.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to work independently and manage workload effectively in a remote environment.
- Understanding of clinical trial processes and regulatory submission requirements.
Remote Pharmacovigilance Scientist
Posted 10 days ago
Job Viewed
Job Description
Qualifications:
- Degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety.
- In-depth knowledge of global pharmacovigilance regulations (e.g., GVP, FDA regulations).
- Experience with adverse event databases and reporting systems.
- Strong analytical, scientific reasoning, and critical thinking skills.
- Excellent written and verbal communication skills.
- Ability to work autonomously and manage multiple projects simultaneously.
- Experience in signal detection and benefit-risk assessment is highly desirable.
Senior Pharmacovigilance Scientist
Posted 12 days ago
Job Viewed
Job Description
Key Responsibilities:
- Collect, assess, and process adverse event reports from various sources, including spontaneous reports, clinical trials, and literature.
- Perform signal detection and evaluation to identify potential safety issues.
- Author and review periodic safety update reports (PSURs), developmental safety update reports (DSURs), and other regulatory submissions.
- Contribute to the development and maintenance of risk management plans (RMPs) and risk-benefit assessments.
- Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
- Liaise with regulatory authorities and business partners on safety-related matters.
- Provide safety training and support to internal stakeholders.
- Participate in cross-functional teams to address product safety concerns.
- Contribute to the development and implementation of pharmacovigilance processes and systems.
- Stay updated on evolving regulatory requirements and scientific advancements in pharmacovigilance.
- Bachelor's or Master's degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field.
- Minimum of 5-7 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations and reporting requirements.
- Experience with adverse event data management systems and signal detection methodologies.
- Strong analytical, critical thinking, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory information.
- Proficiency in medical terminology and coding conventions (e.g., MedDRA, WHODrug).
- Ability to manage multiple priorities and work effectively in a team-oriented environment.
- Experience with risk management strategies is highly desirable.
Senior Pharmacovigilance Scientist
Posted 20 days ago
Job Viewed
Job Description
- Monitor and evaluate safety data from clinical trials, post-marketing studies, and spontaneous reports.
- Perform signal detection and assessment for potential new safety concerns.
- Conduct thorough risk-benefit analyses of investigational and marketed products.
- Prepare and review aggregate safety reports (e.g., DSURs, PBRERs) for submission to regulatory authorities.
- Contribute to the development and implementation of safety management plans.
- Collaborate with clinical teams to ensure robust safety surveillance in ongoing trials.
- Respond to safety inquiries from regulatory agencies and internal stakeholders.
- Participate in safety review meetings and provide expert safety input.
- Stay abreast of evolving regulatory requirements and industry best practices in pharmacovigilance.
- Mentor and guide junior pharmacovigilance staff. Qualifications:
- Advanced degree (M.Sc., Ph.D., Pharm.D., M.D.) in a relevant scientific or medical field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety.
- Comprehensive knowledge of pharmacovigilance principles, regulatory guidelines, and safety databases.
- Proven experience in signal detection, data analysis, and risk assessment.
- Excellent scientific writing and communication skills, with the ability to author complex safety reports.
- Experience with regulatory submissions and interactions.
- Strong analytical and critical thinking skills.
- Ability to work independently and manage workload effectively in a remote setting.
- Proficiency in safety databases and pharmacovigilance software.
- Strong collaborative and teamwork skills.
Principal Pharmacovigilance Scientist
Posted 20 days ago
Job Viewed
Job Description
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.
Remote Senior Pharmacovigilance Scientist
Posted 4 days ago
Job Viewed
Job Description
As a Senior Pharmacovigilance Scientist, you will play a key role in safeguarding public health by ensuring the safe use of our client's pharmaceutical products. Your responsibilities will include performing signal detection and validation, authoring safety narratives, contributing to periodic safety update reports (PSURs), and collaborating closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs. The ideal candidate will possess a strong scientific background, extensive experience in pharmacovigilance, and a demonstrated ability to work autonomously in a remote setting. Your expertise will be vital in maintaining the highest standards of drug safety monitoring.
Responsibilities:
- Manage and process adverse event reports from various sources globally.
- Conduct thorough data analysis to detect and evaluate potential safety signals.
- Prepare comprehensive safety narratives and contribute to regulatory submissions.
- Author and review Periodic Safety Update Reports (PSURs) and other regulatory safety documents.
- Collaborate with clinical teams to ensure robust safety monitoring throughout the drug lifecycle.
- Liaise with regulatory authorities regarding safety inquiries and reporting requirements.
- Develop and implement pharmacovigilance processes and best practices.
- Provide expert input on safety aspects of clinical trial protocols and Investigator Brochures.
- Contribute to risk assessment and mitigation strategies for assigned products.
- Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines.
- Advanced degree in Pharmacy, Medicine, Life Sciences, or a related discipline.
- Minimum of 7 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
- Demonstrated expertise in adverse event case processing, signal detection, and risk management.
- In-depth knowledge of international regulatory requirements (e.g., ICH guidelines, FDA, EMA).
- Strong analytical and critical thinking skills, with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to present complex scientific information clearly.
- Proven ability to work independently and manage multiple priorities effectively in a remote environment.
- Experience with pharmacovigilance databases and safety reporting systems.
Be The First To Know
About the latest Senior pharmacovigilance scientist Jobs in United Kingdom !
Senior Pharmacovigilance Scientist (Remote)
Posted 17 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct in-depth analysis and evaluation of adverse event data from various sources (clinical trials, post-marketing surveillance, literature).
- Prepare comprehensive safety reports, including Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to ensure timely and accurate safety reporting.
- Monitor and interpret global regulatory requirements related to pharmacovigilance and ensure compliance.
- Identify potential safety signals and conduct signal detection activities.
- Develop and deliver training on pharmacovigilance principles and procedures to internal stakeholders.
- Participate in health authority inspections and audits.
- Manage and mentor junior members of the pharmacovigilance team.
- Contribute to the continuous improvement of pharmacovigilance systems and processes, leveraging remote collaboration tools effectively.
- Advanced degree in a life science, pharmacy, medicine, or related field (e.g., MSc, PharmD, PhD).
- Minimum of 7 years of experience in pharmacovigilance or drug safety, with a significant portion in a scientist or analytical role.
- In-depth knowledge of global pharmacovigilance regulations (e.g., GVP, FDA regulations).
- Proven experience in signal detection, risk assessment, and report writing (PSURs, RMPs).
- Experience with safety databases and data analysis tools.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to clearly articulate complex scientific information.
- Ability to work independently and manage multiple projects simultaneously in a remote setting.
- Proficiency in English is essential; knowledge of other languages is a plus.
- Experience with cross-functional team collaboration and project management in a remote environment.
Lead Process Safety Engineer - Pharmaceutical Manufacturing
Posted 13 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and implement comprehensive Process Safety Management (PSM) programs, aligning with international standards such as OSHA PSM and Seveso III.
- Lead and execute Hazard and Operability (HAZOP) studies, Hazard Identification (HAZID), Layer of Protection Analysis (LOPA), and Failure Modes and Effects Analysis (FMEA) for complex chemical processes.
- Develop and manage Process Hazard Analysis (PHA) procedures, ensuring regular reviews and updates.
- Oversee the Management of Change (MOC) process, ensuring all modifications to processes, equipment, or procedures are rigorously evaluated for safety implications.
- Investigate process safety incidents, deviations, and near misses, identifying root causes and implementing effective corrective and preventive actions.
- Develop and deliver advanced training programs on process safety principles and best practices to engineers, operators, and management.
- Ensure compliance with all relevant national and international safety regulations and industry standards.
- Act as a subject matter expert (SME) for process safety, advising project teams, R&D, and manufacturing sites globally.
- Contribute to the design and modification of processes and equipment to inherently safer standards.
- Champion a proactive safety culture across the organisation through effective communication and engagement.
Qualifications and Experience:
- BSc/MSc in Chemical Engineering, Mechanical Engineering, or a closely related discipline.
- A minimum of 8 years of progressive experience in process safety engineering, with a significant portion within the chemical, pharmaceutical, or petrochemical industries.
- Demonstrated expertise in conducting various types of risk assessments (HAZOP, LOPA, HAZID, FMEA).
- Thorough understanding of PSM elements and regulatory requirements.
- Experience with incident investigation methodologies and root cause analysis.
- Strong knowledge of safety instrumented systems (SIS) and relief system design.
- Excellent analytical, problem-solving, and decision-making abilities.
- Exceptional communication, influencing, and stakeholder management skills.
- Ability to work independently and manage multiple priorities effectively in a remote setting.
- Professional certifications in process safety (e.g., CCPSC) are highly advantageous.
Lead Process Safety Engineer - Remote Pharmaceutical
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Lead the design and implementation of process safety management (PSM) programs.
- Conduct and facilitate comprehensive hazard identification and risk assessment studies (e.g., HAZOP, LOPA).
- Develop and review Safety Integrity Level (SIL) assessments and instrumented safety functions.
- Provide expert advice and guidance on process safety to project engineering teams.
- Ensure compliance with relevant national and international safety regulations and standards.
- Develop and deliver process safety training to internal teams and stakeholders.
- Investigate process safety incidents and near misses, identifying root causes and recommending corrective actions.
- Author and review process safety documentation, including safety reports and operating procedures.
- Champion a strong safety culture and promote best practices across the organisation.
- Stay abreast of emerging trends and technologies in process safety engineering.
- Bachelor's or Master's degree in Chemical Engineering or a related discipline.
- Significant experience in process safety engineering within the chemical or pharmaceutical industry.
- Demonstrated expertise in hazard analysis and risk assessment techniques.
- Strong knowledge of relevant safety standards and regulations (e.g., COMAH, OSHA PSM).
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills.
- Ability to manage multiple projects simultaneously in a remote setting.
- Chartered Engineer status or equivalent is highly desirable.