Senior Scientific Director driving pharmacovigilance and risk management for GSK's product portfolio. Leading scientific expertise and cross-functional teams to ensure patient safety across clinical and post-marketing settings.
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 and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
Makes recommendations for the further characterization, management, and communication of safety risks.
Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.
Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Requirements
PhamD/PhD for Scientist (preferred)
Bachelors of Science in Life Sciences or Medical Sciences (minimum standard)
10+ years experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
Significant pharmacovigilance experience (10+ years) 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.
Experience working in large matrix organizations
Benefits
health care and other insurance benefits (for employee and family)
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