Join a leading biopharmaceutical company as a Pharmacovigilance Physician in Amsterdam. Focus on evaluating safety cases from scientific literature to ensure patient safety. Collaborate with cross-functional teams and contribute to safety signal detection and risk management. This role offers a unique chance to apply medical expertise in safeguarding health. Enjoy a dynamic work environment and the opportunity to strengthen the global safety profile of therapies. Uncover the reasons why this opportunity is worth considering.

Over het bedrijf

Panda International

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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 via de button "Solliciteer nu" op deze pagina. or reach out directly at +31 20 20 44502 to learn more.

Gerelateerde zoekopdrachten

Fulltime Amsterdam Tijdelijk contract Amsterdam Amsterdam Provincie Noord-Holland

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