Senior Manager, Global Patient Safety Operations

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned Revolution Medicines’ clinical programs.

• Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

• Represent Global Patient Safety in different cross functional team meetings.

• Collaborate with other functional groups to achieve clinical program goals.

• Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

• Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

• Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

• Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

• Support the execution and maintenance Safety Data Exchange Agreements.

• Pharmacovigilance Agreements with business partners.

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.

• Support Global Patient Safety team in other PV activities appropriate to experience and expertise.

• May oversee or be responsible for one or more junior team member(s).