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Pharmacovigilance Physician – Literature Case Review

LocationAmsterdam, Netherlands
Business SectorBiotechnology
Contact email
Job ref25838
Publishedabout 2 hours ago
Pharmacovigilance Physician – Literature Case Review
Amsterdam, Netherlands – Full-time, 3-month contract

Company Description
A leading biopharmaceutical company specializing in plasma-derived medicinal products, with a strong commitment to patient safety and regulatory excellence. Operating from our Amsterdam site, we ensure the highest standards of drug safety monitoring to support the responsible use of our therapies.

Job Description
As a Pharmacovigilance Physician – Literature Case Review, you will join the Drug Safety team within Medical Affairs. Your primary responsibility will be the medical evaluation of literature-derived safety cases for the products. You will assess adverse events reported in scientific publications, determine regulatory reportability, and contribute to safety signal detection and risk management activities.

Reporting to the Head of Medical Affairs, you will work cross-functionally with safety scientists, regulatory affairs, and medical affairs colleagues to ensure compliance with global pharmacovigilance regulations. This role offers an excellent opportunity to apply your medical expertise to safeguard patient health and strengthen the global safety profile.

Key Responsibilities:
  • Screen and evaluate scientific literature for potential Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) related to Nanogam, Cofact, and Albuman
  • Perform medical review including seriousness, expectedness, and causality assessment of identified cases
  • Determine regulatory reportability in line with EMA, FDA, and ICH guidelines
  • Write medical comments, propose follow-up actions, and conduct analysis of similar events (AoSE) to identify safety patterns
  • Support signal detection activities and contribute to periodic safety reports (PSURs, DSURs) and Risk Management Plans (RMPs)
  • Ensure accurate documentation in safety databases and trackers while maintaining compliance with global regulatory standards
  • Collaborate with the Qualified Person for Pharmacovigilance (QPPV) and cross-functional teams on safety strategy
Essential Requirements:
  • Medical degree (MD or equivalent)
  • 1–2 years’ experience in pharmacovigilance or clinical medicine
  • Familiarity with MedDRA coding, ICH guidelines, and global PV regulations
  • Experience with literature screening tools and safety databases (e.g., Embase, PubMed, Argus, ARISg)
  • Strong analytical and written communication skills
  • Fluent in English (both written and spoken); additional languages an advantage
Desirable Experience:
  • Prior experience with plasma-derived or blood-related products
  • Knowledge of immunoglobulins, coagulation factors, and albumin pharmacology
  • Exposure to signal detection and aggregate safety report writing

Additional Insights:
  • Location: Amsterdam, Netherlands
  • Contract Type: 3-month contract
  • Start Date: ASAP
  • Language Requirements: English required; additional languages a plus

Interested?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com or reach out directly at +31 20 20 44502 to learn more.