SERM Medical Director / SERM Scientific Director

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Job Purpose Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets for complex Classic & Established Products with ongoing litigation. Ensures scientifically sound review and interpretation of large and complex datasets, management of safety issues and escalates issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for further characterization, management and communication of safety risks. Scientific/Medical Knowledge PV Expertise • 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. • Expert evaluation skills and analytical thinking for complex data synthesis, analysis and interpretation. • Demonstrated track record of quality decision making and creative problem solving, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context. • Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high-performance standards for quality. Safety governance and cross-functional matrix leadership • Leads safety governance by development of safety strategy and its execution for Classic & Established Products. • Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately. • Leads and facilitates Safety Review Teams/safety governance to detect and address product safety issues and ensures that endorsed risk-reduction strategies are implemented appropriately. • Leads discussions/interactions with Global asset and litigation lawyers. • Leads cross-functional ad hoc teams to address urgent and important product safety issues. • Accountable for the escalation of issues and communication on safety matters (e.g., GSB, GLC, QPPV). • Builds strong working relationships and exemplifies excellent leadership skills on safety issues with a demonstrated ability to lead, coach and mentor others. Communication, Influencing and Inspection readiness • Leads presentations on recommendations of safety issues to senior staff members at the GSK Senior Governance Committees. • Has the skillset to interact with confidence, credibility and influence at all levels of the GSK organisation. • Represent GSK and actively contribute to safety-related discussions with health authorities, external consultants, partner companies (e.g. licensing partners), and during legal depositions • Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. • Must have an inspection readiness mindset and be prepared as needed to support audits/inspections at short notice. Basic Requirements Candidates must meet the requirements for both roles and all requirements for th