Clinical Trial Expert

3 weeks ago

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

We are looking for an experienced Clinical Trial Expert to join our team at Planet Pharma. In this role, you will be responsible for providing pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data.

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: $110,000 - $150,000 per year, depending on location and experience

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