For a pharmaceutical company in the area of Zaventem, we are looking for a pharmacovigilance officer.
- Do you have a first experience in clinical research or do you have a good knowledge of the methodology of clinical trials?
- Are you accurate, conscientious and detail-oriented?
- Do you have a good knowledge of Dutch, French and English?
Please contact me for more information!
The Pharmacovigilance (PV) Officer reports correctly and in time the drug safety information in the territory both to the respective Health Authorities and to Corporate Pharmacovigilance & Risk Management (PV & RM) department. He/she tracks, evaluates and reports the adverse events of the company conform the legal and corporate requirements.
- Reviewing, assessing and processing safety data for phase I, II & III clinical trials and marketed products.
- Maintaining information about all SAEs/ADRs in a secure location, in accordance with local regulations.
- Tracking of regulatory guidelines and directives related to Medical Affairs department activities.
- Maintaining a ‘list of Authorities and other official bodies’ to whom SAEs/ADRs should be reported, as well as corresponding reporting procedures.
- Review of listings, concomitant therapy, line listings, clinical trial protocols, …
- Report writing: narratives, DSURs, PSURs, product-related expert reports, ISSs, Clinical Expert Statements/Clinical overviews for registration renewal purpose, involvement in the writing of the safety section of the IB, SDEA, SPP,…
- Direct reports, backup and internal/external communication.
- You have a good medical/pharmacology knowledge
- Good knowledge of clinical research
- Knowledge of epidemiology
- Good presentation and training skills
- Accurate and detail oriented
- You show strong planning skills and easily respect timelines
- You can work autonomously
- Good MS office skills (Excel)
- You are fluent in English, knowledge of French or Dutch is an asset
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