Medical Director providing in-depth expertise in safety evaluation and risk management for GSK's clinical development. Collaborating to ensure patient safety globally through pharmacovigilance and oversight of safety issues.
Responsibilities
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.
Ensures scientifically sound review and interpretation of data and management of safety issues
Makes recommendations for the further characterization, management, and communication of safety risks.
Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Requirements
Medical degree
Completion of a formal postgraduate clinical training, clinical residency or specialty training
Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Experience with Signal Detection and safety surveillance
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
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