Senior Medical Director, Pharmacovigilance

We are seeking a Senior Medical Director, Pharmacovigilance to support global pharmacovigilance for marketed and/or investigational products. In this role, you will be responsible for overseeing activities such as medical review of cases, signal management, aggregate reports, risk management, ad hoc safety query responses, literature surveillance, safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (protocols, IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable) while serving as a key medical expert in cross-functional teams and regulatory interactions.  Key Responsibilities: Lead benefit risk for the assigned products Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned products throughout the life cycle of the compound. Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation Oversee team contributions to safety-critical documentation such as regulatory submissions (INDs, NDAs, MAAs) Attend/lead Safety Committee meeting to support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments Participate in development and maintenance of risk management plans (RMPs) and REMS as applicable. Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports as needed Contribute to preparation of relevant regulatory documents and responses to regulatory agencies, Institutional Review Board (IRB), Investigational Site and Medical Information queries Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed Lead the medical review activities for ICSRs  Perform medical review and assessment of adverse event reports for marketed and investigational products, including review of coding, consistency in assessment, case narrative, company assessment and case documentation  Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment Adhering to documented procedures and company/vendor timelines for ICSRs submission Attend Kick-Off meetings, weekly case medical review, study team meetings, and vendor meetings, and other meetings as needed or requested. Lead the safety related sections of the study documents Ensure appropriate safety content of the study documents such as study protocol (s), Investigator Sponsored Research (ISR), Investigator Brochure /Reference Safety Information, Informed Consent Form risk language Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion criteria, and issues of patient safety and/or eligibility, IRB responses for safety related queries Present and lead safety data presentation in Data Monitoring Committee (DMC) and participate in data review meetings Other duties and responsibilities as assigned