Medical Affairs Officer - Pharmacovigilance
Full-time permanent position
Office based near Bristol
Competitive package and possible relocation assistance
Pharmacovigilance System Master File (PSMF): Maintenance of the Pharmacovigilance System and PSMF.
Quality Management Systems: Maintaining the PV Quality Management System and
undertaking associated quality???related activities including Audit, Compliance Monitoring and Quality Improvement. SOP authoring and management.
Post???marketing safety data: Processing and reporting spontaneously received post???marketing safety data including its receipt, tracking, coding, assessment and submission to regulatory authorities.
Safety Data Management: Maintenance of cumulative safety data received from all sources including spontaneous reports, literature sources, National Regulatory Authorities and the EMA
Literature review: Review of safety information published in the scientific literature.
Signal Management: Signal management from signal detection through to assessment and recommendation for action.
Risk Management and Minimisation: Production, review and maintenance of Risk Management
Plans and implementation of risk minimisation activities including effective use of product labelling and (when required) additional materials.
EudraVigilance: Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information.
Pharmacovigilance Agreements: Production, review and maintenance of effective Safety Data
Exchange Agreements between the company and its business partners. Product Maintenance & Development: Authoring of safety???related information including updates to product labelling (SmPC, PIL, packaging) and coordination of associated regulatory activities. Supporting new MA applications, lifecycle maintenance and renewal activities.
Full job description available on application
A degree in the Life Sciences. A degree in Pharmacy or an additional postgraduate degree would be an advantage.
A minimum of 3 to 5 years of relevant (post???marketing) EU Pharmacovigilance experience.
A clear understanding of the current and developing legislation and the ability to apply this to the company Pharmacovigilance System and processes.
Outstanding communication and medical writing skills with exceptional attention to detail
Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on or email
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Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.