• Lead strategic relationships with PVRM and non-PVRM vendors • Provide strategic oversight of adverse event (AE) management and reporting processes • Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality • Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits • Develop and maintain PV staff learning plans, manage compliance activities • Oversee development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems • Support global safety planning and coordination, maintain relationships with business partners, affiliates, and subsidiaries • Provide expert support for Pharmacovigilance Agreements (PVAs) • Mentor and coach team members