• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks • Contribute to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms, IB Reference Safety Information, Publications, and other relevant documents • Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations • Support inspection readiness and provide expertise in audits, inspections, and CAPAs • Perform medical review of Individual Case Safety Reports • Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information • Provide leadership in regulatory authority interactions regarding safety and risk management • Support the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities • Assist in the maintenance of Global PVRM related cross-functional SOPs in compliance with global safety regulations and guidelines and lead corporate initiatives and inspection readiness