Pharmacovigilance Manager

3 weeks ago

London, Greater London, United Kingdom Planet Pharma Full time
About the Role

We are seeking an experienced Pharmacovigilance Manager to join our team at Planet Pharma. As a key member of our safety team, you will be responsible for ensuring compliance with regulatory requirements and providing pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs.

Key Responsibilities:

  • Maintain Safety Monitoring Plans, study plans, metrics, KPIs, and contractual agreements
  • Lead PV compliance, inspection, and audit readiness for Argus, KPIs, and safety management topics
  • Oversee ICSR workflow, case management activities in Argus (or other safety databases), ensuring critical timelines and compliance
  • Provide pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data
  • Perform peer review of cases in safety databases, including adverse event coding, report tracking, and regulatory reporting as needed
  • Triage incoming cases, assess seriousness, expectedness, and causality, and write high-quality case narratives for medical review
  • Stay updated on regulatory requirements for safety management in Expanded Access and Compassionate Use Programs (EAPs/CUPs)
  • Produce and submit safety reports (e.g., CIOMS/MedWatch Forms) to regulatory authorities, ensuring compliance with timelines

Requirements:

  • Bachelor's Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
  • Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
  • Proficient with International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines and other applicable regulatory rules and guidelines, as well with medical terminology, clinical trials and clinical research
  • Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
  • Action-oriented and resilient in a fast-paced environment with strong project team skills and ability to mentor, delegate and motivate others
  • Ability to communicate effectively with clients, internal teams and vendors and soft skills to build and maintain trust and confidence
  • Strong understanding of global safety regulations, medical terminology, and drug development process
  • Estimated salary: $120,000 - $160,000 per year, depending on location and experience

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