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.
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
Leads the safety component of global regulatory submissions.
Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams.
Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting.
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees.
Leads cross-functional process improvement team within GSK.

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.
Experience working in large matrix organizations

SERM Medical Director

Key skills