Senior Director, Pharmacovigilance Sciences Lead

Role Summary: The Senior Director, Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio.The Senior Director, Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable). The Senior Director, Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives, strategic innovations, and team leadership. Key Responsibilities:Oversees PV Sciences deliverables across the portfolio – 50%    Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations, including:Signal detection, evaluation, and managementAggregate safety reports (DSURs, PADERs, PBRERs)Risk management plans (including maintenance and implementation of risk minimization measures)Literature surveillanceSafety governance meeting preparation and documentationSafety-related regulatory query responsesSafety-related contributions to key documents (IB/RSIs, CCDS/labels, ICF, etc.)Contributions to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorisation Applications)Inspection preparation and execution Strategic leadership, management, and mentorship – 50%Sets strategy for the PV Sciences team, aligning with corporate goals and safety objectives, and ensures that relevant goals are metLeads recruitment, mentoring, career development, and performance management of PV Sciences teamCollaborate with cross-functional teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain integrated safety oversight.Leads process improvements and conducts impact assessmentsEnsures appropriate training and individual development for direct and indirect reportsOther duties and responsibilities as assigned