Drug Safety Officer
2 weeks ago
Pharmacovigilance Officer
Pharma-Partners are currently working with a global pharmaceutical company that specialises in the supply of injectable medicines to a variety of customers. With a diverse portfolio and a global presence out of the UK 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.
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.
- Literature review: Systematic review of safety information published in the worldwide scientific literature in partnership with third party service providers.
- Case processing of ICSRs, including data entry in the Safety Database, assessment and triage.
- 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.
- Aggregate safety reports. Authoring/ co-authoring/ reviewing aggregate safety reports (PSURs, PBRERs) alongside colleagues from the Medical Affairs team.
- 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. strategies and plans for key customer groups including but not limited to payers, policy makers and advocates across relevant geographies
The Candidate:
- A degree in the Biological or Biomedical Sciences. An additional postgraduate degree would be an advantage.
- Relevant experience in Pharmacovigilance and Medication/ Patient safety.
- A clear understanding of current and developing legislation, ethics and practice and the ability to apply this to company processes.
- Outstanding communication and medical writing skills with exceptional attention to detail - the ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers including business partners and healthcare professionals.
- An understanding of the principles of information management including data sources, gathering, assessment and storage.
- The ability to build and maintain effective working relationships with cross-functional and multi-national colleagues.
- The ability to meet deadlines while managing multiple responsibilities.
- Professionalism and integrity.
Remuneration:
- Competitive basic annual salary plus benefits package
To apply for this position please use the "Apply" option or feel free to send your CV directly to Freddie.hill@pharma-partners.co.uk
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