The position is part of the Drug Safety Unit office of IBSA. The Drug Safety Unit is responsible for the collection, detection, assessment, monitoring, and prevention of adverse effects related to IBSA’s pharmaceutical products (Pharmacovigilance).
Main responsibilities and tasks
Collection, recording and management of EU and extra-EU adverse events/reactions (AE/ADR) from any source in agreement with the enforced legislations.
Triage evaluation (categorisation with regard to validity, seriousness, expeditedness and submission rules) in agreement with SOP and the enforced legislation.
Data entry and of quality control ICSRs and SUSARs in the Safety database and in EudraVigilance (EVPM and EV-CT Module).
Identifying relevant missing information for follow-up request.
Collection and recording of technical complaints and of the safety related issues.
Reporting to IBSA group and partners companies of safety reports according to the pharmacovigilance agreements and the enforced legislations.
International scientific literature periodic review for all IBSA products/active principles.
Academic degree in Pharmacy, Biology, Chemistry or Pharmaceutical Chemistry.
Excellent knowledge of English written and spoken.
Good knowledge of German or French.
Previous experience in the area of competence.
We are looking for an open minded analytical thinking person, which is capable to resolve complex matters, team work oriented and highly motivated.
IBSA Institut Biochimique SA in Pambio-Noranco, Ticino, Switzerland.
Scientific Research and Development
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