Medical Director, Safety Evaluation and Risk Management

GSK · Warsaw · PLN 419,250 to PLN 698,750 · hybrid 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. This role 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. Responsibilities Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. 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. Makes recommendations for further characterization, management and communication of safety risks. Leads safety governance by development of safety strategy and its execution for Classic & Established Products. Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately. Leads and facilitates Safety Review Teams/safety governance to detect and address product safety issues. 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. Builds strong working relationships and exemplifies excellent leadership skills on safety issues. Leads presentations on recommendations of safety issues to senior staff members at the GSK Senior Governance Committees. Interacts with confidence, credibility and influence at all levels of the GSK organisation. Represents GSK and actively contributes to safety-related discussions with health authorities, external consultants, partner companies and during legal depositions. Requirements Relevant degree qualification. Experience in the pharmaceutical or biotechnology industry in Pharmacovigilance, Drug Safety, Clinical Development, or a related field. Pharmacovigilance experience in safety evaluation and risk management involving clinical-development or post-marketing products. Knowledge of international pharmacovigilance requirements and frameworks. Knowledge of drug-development and regulatory-approval processes. Experience working in a cross-functional matrix organization. Medical Doctor or equivalent physician qualification, such as an MD, MBBS, MBChB, or equivalent primary medical degree. Completion of formal postgraduate clinical training. Medical and scientific expertise relevant to safety evaluation and risk management. Benefits Salary range: PLN 419,250 to PLN 698,750 or EUR 95,250 to EUR 158,750 Annual bonus and eligibility to participate in share-based long-term incentive program Private medical care, additional paid holidays, life insurance, private pension plan, and fully paid parental leave