Drug Safety Physician
Our client is a leading biopharmaceutical company currently looking for a Drug Safety Physician, who will be responsible for the overall medical evaluation of adverse event information, conduct routine Pharmacovigilance, initiate safety-related product labelling changes based on risk assessment, and prepare safety evaluations for regulatory reports.
- Management of adverse event information – ICSR processing activities
- 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
- Produce and maintain the Development Pharmacovigilance 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:
- Medical Doctor 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