Senior Manager, Global Patient Safety Operations

Revolution Medicines•Redwood City, CA

1d•$261,000 - $300,000•Hybrid

About The Position

This position manages, develops, and oversees Global Patient Safety operational activities for the execution of safety information collection and reporting for assigned Revolution Medicines clinical programs. The role contributes to operational objectives, policies, and procedures; represents Global Patient Safety in cross-functional meetings; and collaborates with other groups to achieve clinical program goals. The Senior Manager oversees pharmacovigilance contract research organizations (PV CROs), ensuring safety reporting meets required timelines, issues are communicated, and resolutions are achieved promptly. The role oversees safety reporting to global regulatory authorities, central IRBs and ethics committees, and investigators; ensures global safety reporting and safety databases are set up accurately and on time; and supports clinical and pharmacovigilance documentation and processes. The position may oversee or be responsible for one or more junior team members.

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 or vendors and managing external resources.
Strong background in safety reporting regulatory compliance and global safety reporting and regulations in clinical trials.
Ability to problem-solve, focus on details, multitask, prioritize options, work independently, anticipate challenges, and execute assigned deliverables.
Ability to analyze situations and data requiring conceptual thinking and in-depth knowledge of organizational objectives.
Ability to persuade others in sensitive or complex situations while maintaining relationships.
Innovative team player able to work effectively in a dynamic, continuously improving, fast-paced company environment.
Excellent interpersonal skills, including the ability to work in cross-functional teams and with external vendors.
Ability to exercise discretion regarding highly confidential internal and external communications.

Nice To Haves

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

Responsibilities

Manage, develop, and oversee Global Patient Safety operational activities for safety information collection and reporting in assigned clinical programs.
Participate in developing Global Patient Safety Operations objectives, policies, and procedures.
Represent Global Patient Safety in cross-functional team meetings and collaborate with other functional groups to achieve clinical program goals.
Oversee PV CRO execution of safety reporting in clinical studies.
Manage PV CROs to ensure compliance with required timelines, communication of potential issues, and timely resolution.
Oversee safety report submissions to global regulatory authorities, central IRBs and ethics committees, and investigators in compliance with global regulatory requirements.
Ensure timely and accurate setup of global safety reporting and safety databases for assigned clinical programs.
Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochures (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 on SAE reconciliation and SAE query resolution.
Support other Global Patient Safety pharmacovigilance activities appropriate to experience and expertise.
May oversee or be responsible for one or more junior team members.