Manager, External Affairs

Position Summary: This is a global role which supports the Patient Safety (PS) Mission and Vision through understanding the impact of daily work on all stakeholders of Safety Management Plans (SAE MPs) and Pharmacovigilance Agreements (PVAs).This role provides oversight of quality and process optimization working with multiple global stakeholders across PS and external functions to ensure business critical support to the management of and reporting associated with SAE MPs and PVAs. Major responsibilities will be the drafting, review, negotiation, execution and maintenance of SAE MPs and PVAs as assigned. Duties Responsibilities: Demonstrate strong teamwork skills to ensure accurate production of SAE MPs and PVAs including the processes, procedures, and best practices are consistent across PS and that regulatory requirements are met in a timely manner and with high quality Periodically review and update SAE MPs and PVAs per internal process Builds and maintains strong relationships with other BMS functional areas to complete and facilitate implementation of SAE MPs and PVAs Identifies ways to improve productivity and quality standards for SAE MP and PVA-related deliverables and actively participates in efforts to remedy non compliance situations Review and evaluate integrity of CRO SAE management processes for inspection readiness. Apply knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations to maintain oversight of SAE MPs and PVAs and ensure successful execution of task Engage and develop working relationships with Preferred CROs and Business Partners to ensure alignment with BMS processes. Maintain a customer service focus with internal and external colleagues. Take personal initiative by proactively identifying innovative ways to accomplish tasks and drive toward process efficiencies. Utilize effective organizational skills to prioritize deliverables to accomplish work in established timeframes. Contribute to continuous quality improvement process through projects and other related departmental initiatives. Develop expertise in associated applications and web systems (e-TMF, Veeva Vault, PVA and SAE MP Management system.

Location: hyderabad, IN

Posted Date: 6/11/2025