REVOLUTION Medicines
Associate Director, Global Patient Safety Operations
REVOLUTION Medicines, Redwood City, California, United States, 94061
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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.
Develops and executes Global Patient Safety Operations operational objectives, policies, and procedures. Participates in establishing strategic plans and objectives with senior management. Collaborates with senior internal and external representatives to achieve objectives. 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. Executes and maintains 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. Oversee or be responsible for one or more direct reports. Required Skills, Experience and Education:
Bachelor's degree in a healthcare field Minimum of 7 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 Preferred Skills:
Master's Degree or higher in a healthcare field 9+ years of relevant experience in pharmacovigilance operational activities Experience working with investigator sponsored trials, extended use programs, and business partnerships Experience working on late phase clinical and post-marketing safety reporting activities
The base salary range for this full-time position is $175,000 to $210,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-VN1
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.
Develops and executes Global Patient Safety Operations operational objectives, policies, and procedures. Participates in establishing strategic plans and objectives with senior management. Collaborates with senior internal and external representatives to achieve objectives. 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. Executes and maintains 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. Oversee or be responsible for one or more direct reports. Required Skills, Experience and Education:
Bachelor's degree in a healthcare field Minimum of 7 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 Preferred Skills:
Master's Degree or higher in a healthcare field 9+ years of relevant experience in pharmacovigilance operational activities Experience working with investigator sponsored trials, extended use programs, and business partnerships Experience working on late phase clinical and post-marketing safety reporting activities
The base salary range for this full-time position is $175,000 to $210,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-VN1