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Pharmacovigilance Safety Officer
2 months ago
Pharma-Partners are currently working with a global pharmaceutical company that specializes in the supply of injectable medicines to a variety of customers.
This is a great opportunity for someone with a solid grounding within drug safety/pharmacovigilance to expand on their experience, work within a wider medical affairs function, and develop professionally.
Key Responsibilities:- Safety Data Management: Review of safety data received from all sources, including spontaneous reports from patients and healthcare professionals, literature sources, MHRA, EMA, and National Regulatory Authorities worldwide.
- Systematic Review: Systematic review of safety information published in the worldwide scientific literature in partnership with third-party service providers.
- Case Processing: Case processing of ICSRs, including data entry in the Safety Database, assessment, and triage.
- 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.
- Aggregate Safety Reports: Authoring/co-authoring/reviewing aggregate safety reports (PSURs, PBRERs) alongside colleagues from the Medical Affairs team.
- Safety-Related Information: Authoring of safety-related information, including updates to product labelling (SmPC, PIL, packaging) and coordination of associated regulatory activities.
- A degree in the Biological or Biomedical Sciences.
- An additional postgraduate degree would be an advantage.
- Relevant experience in Pharmacovigilance and Medication/Patient safety.
- Outstanding communication and medical writing skills with exceptional attention to detail.
- An understanding of the principles of information management, including data sources, gathering, assessment, and storage.
Competitive basic annual salary plus benefits package
