Drug Safety Physician

Reference Number: 895887-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

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.

Main Responsibilities:

  • 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

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