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Medical Affairs Professional

2 months ago


Cheltenham, Gloucestershire, United Kingdom Pharma Partners Recruitment Ltd Full time
Job Description

Pharmacovigilance Officer

Pharma Partners Recruitment Ltd is currently working with a global pharmaceutical company that specializes in the supply of injectable medicines to a variety of customers. With a diverse portfolio and a global presence, 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, regulatory authorities worldwide, and other relevant data.
  • Literature Review: Systematic review of safety information published in the worldwide scientific literature in partnership with third-party service providers.
  • Case Processing: Processing of Individual Case Safety Reports (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 Minimization: Production, review, and maintenance of Risk Management Plans and implementation of risk minimization activities, including effective use of product labeling and additional materials.
  • Aggregate Safety Reports: Authoring, co-authoring, and 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 labeling (SmPC, PIL, packaging), and coordination of associated regulatory activities. Supporting new marketing authorization applications, lifecycle maintenance, and renewal activities.

The Ideal 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, and the ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers.
  • 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.

What We Offer:

  • A competitive basic annual salary, plus benefits package.