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Senior Manager, Global Patient Safety Operations

$164k - $205k

Revolution Medicines

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: daraxonrasib (RMC‑6236), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805), and RMC‑5127, all 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. The Opportunity 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. Participate in the development of Global Patient Safety Operations operational objectives, policies, and procedures. Represent Global Patient Safety in cross‑functional team meetings. Collaborate with other functional groups to achieve clinical program goals. Oversee the Pharmacovigilance Contract Research Organization (PV CRO) execution of safety reporting in clinical studies. Manage PV CROs to ensure compliance with required timelines, communicate potential issues, and achieve timely resolution. Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure compliance with global regulatory requirements. Ensure timely and accurate setup 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 of Safety Data Exchange Agreements and 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 (Clinical and Post‑Marketing) appropriate to experience and expertise. May oversee or be responsible for one or more junior team member(s). Required Skills, Experience and Education 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 managing 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. Preferred Skills 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. Base Pay Salary Range for this full‑time position: $164,000 – $205,000 USD (on‑site at Redwood City, CA). The salary is intended for the base pay only and will be adjusted for the local market and based on individual qualifications. Revolution Medicines is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, medical condition, and veteran status. #J-18808-Ljbffr Revolution Medicines

Vacancy posted 4 days ago
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