Site Name: Italy - Siena, Belgium-Wavre, GSK HQ, Poznan Grunwaldzka Posted Date: Apr 9 2025 In this position you will provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. You will ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. Further responsibilities: Responsible for signal detection and evaluation activities for assigned products. Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician). Author the SERM safety contribution to global regulatory submissions in partnership with the product physician. Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensure that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling. Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency. Present complex issues to senior staff members at the GSK Senior Governance Committees. Participate in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation. Basic Qualifications & Skills: Education: Medical Doctor (physician) with additional relevant medical or scientific post-graduate qualifications Pharmacovigilance experience relating to Safety Evaluation and Risk Management, including strong background in early clinical development and/or post-marketing activities Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Experience of having worked in clinical trials Experience working in large matrix organizations Please note that relocation support cannot be provided, therefore only such candidates can be considered, who are already based in the indicated countries. J-18808-Ljbffr