• Leads and manages signal management activities (clinical surveillance, signal identification, validation, analysis and prioritization) and closely collaborates with medical monitors and clinical scientists to provide clinical assessment and recommendations for continuous benefit-risk evaluation throughout the lifecycle of Definium medicinal products, and in compliance with regulatory requirements and company standard operating procedures • Responsible for providing high-level safety expertise in clinical evaluation of all AEs including review of all safety case narratives, aggregate safety data, and relevant literature within or external to the safety database to assess the impact on the benefit-risk profile throughout the lifecycle of Definium products • Leads and collaborates cross-functionally with medical and clinical scientists to develop, implement and maintain risk management activities which may include benefit-risk analysis in sections of clinical trial protocols, Investigators Brochure, informed consents, Clinical Study Reports, periodic reports (DSURs, PBRERs, PADERs), and/or any applicable risk management plans and REMS obligations • Represents PV in collaborating with relevant company stakeholders in the development, review, and/or maintenance of Definium products Reference Safety Information, company core safety information, and other labeling, as required or directed • Prepares and reviews key safety sections of the Investigators Brochure, protocols, informed consents, clinical study reports, and regulatory filings, as required • Provides strategic input into regulatory responses and/or requests and clinical development programs • Serves as a member of the safety governance committee providing safety analysis reports and/or presentations to characterize and communicate changes or key insights into Definium product(s) • Responsible for keeping current with global Pharmacovigilance regulations and industry standards especially as it pertains to risk management and signal management practices • Works collaboratively with internal and external Pharmacovigilance stakeholders and team members to ensure regulatory compliance and maintain Pharmacovigilance quality system • Acts as the Subject Matter Expert in risk management and signal management procedures and processes during audits and inspections