Drug Safety Physician
- Contract Type
- Management of adverse event information – ICSR processing activities:
- Contribute to triage for their respective cases (according to latest international reporting regulations and guidelines);
- Provide good quality medical review of adverse events reports for the responsible products and of adverse events reports for other products as needed;
- Checking for correctness of adverse event/case labeling and causal relationship, association of diagnosis and signs/symptoms and providing medical comments, as appropriate.
- Maintain active pharmacovigilance for the responsible company’s products including accurate signal detection and risk management;
- Identify clinical and post-marketing safety signal or issues (perform signal detection and ad hoc review as appropriate), provide consultation and recommendations regarding medical questions and safety issues;
- Ensure good management of pharmacovigilance issues, accurate update of risk management and risk minimization activities to maintain patient safety to ensure the best safety profile of their responsible product(s);
- Produce and maintain the Development Pharmacovigilance Plan;
- Coordinate Safety Management Team (SMT) activities and meetings;
- Provide medical and safety expertise at SMT;
- Contribute to medical writing, provide good quality input to (and review) the generation of safety reports for marketed and non-marketed products;
- Provide drug safety expertise in all phases of drug development;
- Participate and contribute to Clinical Project Team and Life Cycle Team (LCT) meetings, maintain close contact and good collaboration with CT and LCT members;
- Review, contribute and provide medical and safety expertise for synopsis, protocol, safety amendment, core informed consent (CIC), CRF, CSR, investigator brochures (IB), briefing book (BB), IMPD, SAP, integrated summary of safety (ISS), Clinical Summary of Safety, PIP, clinical development plan;
- Ensure that all actions are appropriately taken for each individual trial: flow of SAE information, ARGUS coding guidelines, inform the clinical trial safety manager for ARGUS setup and for unbinding;
- Provide medical support to affiliates, or contract research organizations.
Qualifications and Experience:
- Doctor of Medicine degree with license or equivalent;
- More than 3 years of international experience in the Drug Safety environment of pharmaceutical industry, and in collecting, analysing, assessing and reporting adverse events associated with investigational and marketed products;
- Knowledge of international safety regulations (primarily EU regulation and ICH);
- Strong verbal and written English communication skills;
- Relevant working/residency permit or Swiss/EU-Citizenship required.