Senior Manager, Global Patient Safety Operations

Revolution Medicines•Redwood City, CA

19d•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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).

Requirements

Bachelor’s degree in a healthcare field.
Minimum of 5 years of relevant experience in pharmacovigilance operational activities.
Hands-on experience working with CROs/vendors and management of external resources.
Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.
Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.
Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.
Ability to persuade others in sensitive/complex situations while maintaining relationships.
An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.
Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.
Exercise discretion regarding highly confidential internal and external communications.

Nice To Haves

Master’s Degree or higher in a healthcare field.
7+ years of relevant experience in pharmacovigilance operational activities.
Experience working with investigator sponsored trials, extended use programs, and business partnerships.

Responsibilities

Management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for assigned clinical programs.
Participation in the development of Global Patient Safety Operations operational objectives, policies, and procedures.
Representing Global Patient Safety in cross-functional team meetings.
Collaboration with other functional groups to achieve clinical program goals.
Overseeing Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.
Managing PV CROs to ensure compliance with required timelines, communication of potential issues, and timely resolution.
Overseeing reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure compliance with global regulatory requirements.
Ensuring timely and accurate setup of global safety reporting and safety database in assigned clinical programs.
Supporting authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.
Supporting the execution and maintenance of Safety Data Exchange Agreements /Pharmacovigilance Agreements with business partners.
Collaborating with other functional groups in SAE reconciliation and SAE query resolution activities.
Supporting the Global Patient Safety team in other PV activities appropriate to experience and expertise.
Potentially overseeing or being responsible for one or more junior team members.