REVOLUTION Medicines
Senior Manager, Global Patient Safety Operations
REVOLUTION Medicines, San Francisco, California, United States, 94199
Overview
Senior Manager, Global Patient Safety Operations. Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for use in combination strategies. As a member of the Revolution Medicines team, you will contribute to patient-focused safety programs with a 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. Responsibilities
Participate in developing Global Patient Safety Operations objectives, policies, and procedures. Represent Global Patient Safety in cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals. Oversee Pharmacovigilance (PV) Contract Research Organizations (CROs) in the execution of safety reporting in clinical studies. Manage PV CROs to ensure timelines are met, communicate potential issues, and achieve timely resolutions. Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure regulatory compliance. Ensure timely and accurate setup of global safety reporting and safety databases for assigned programs. Support authoring and updates of clinical trial protocols, informed consent forms, Investigator's Brochure (including the Reference Safety Information), and aggregate reports. Support the execution and maintenance of Safety Data Exchange Agreements and Pharmacovigilance Agreements with business partners. Collaborate with other functions in SAE reconciliation and SAE query resolution. 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 members. Required Skills, Experience and Education
Bachelors 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 in clinical trials. Ability to problem solve, maintain attention to detail, multi-task, prioritize, work independently, anticipate challenges, and deliver results. Ability to analyze situations and data with conceptual thinking aligned to organizational objectives. Ability to persuade others in sensitive situations while maintaining relationships. Innovative team player able to contribute in a dynamic, fast-paced environment. Excellent interpersonal skills and ability to work in cross-functional teams and with external vendors. Discretion in handling highly confidential communications. Preferred Skills
Masters Degree or higher in a healthcare field. 7+ years of relevant experience in pharmacovigilance operational activities. Experience with investigator-sponsored trials, extended use programs, and business partnerships. Other Details
The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range is for onsite work and may be adjusted for the local market. Individual pay is determined by factors including job skills, experience, market dynamics, and education. Please note that base salary is part of the total rewards program, including competitive cash compensation, equity awards, benefits, and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination on the basis of race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, medical condition, and veteran status. We respect your privacy and process personal data in accordance with our CCPA Notice and Privacy Policy. For information, please contact privacy@revmed.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Referrals increase your chances of interviewing. Get notified about new Safety Manager jobs in San Francisco Bay Area. #J-18808-Ljbffr
Senior Manager, Global Patient Safety Operations. Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for use in combination strategies. As a member of the Revolution Medicines team, you will contribute to patient-focused safety programs with a 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. Responsibilities
Participate in developing Global Patient Safety Operations objectives, policies, and procedures. Represent Global Patient Safety in cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals. Oversee Pharmacovigilance (PV) Contract Research Organizations (CROs) in the execution of safety reporting in clinical studies. Manage PV CROs to ensure timelines are met, communicate potential issues, and achieve timely resolutions. Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure regulatory compliance. Ensure timely and accurate setup of global safety reporting and safety databases for assigned programs. Support authoring and updates of clinical trial protocols, informed consent forms, Investigator's Brochure (including the Reference Safety Information), and aggregate reports. Support the execution and maintenance of Safety Data Exchange Agreements and Pharmacovigilance Agreements with business partners. Collaborate with other functions in SAE reconciliation and SAE query resolution. 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 members. Required Skills, Experience and Education
Bachelors 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 in clinical trials. Ability to problem solve, maintain attention to detail, multi-task, prioritize, work independently, anticipate challenges, and deliver results. Ability to analyze situations and data with conceptual thinking aligned to organizational objectives. Ability to persuade others in sensitive situations while maintaining relationships. Innovative team player able to contribute in a dynamic, fast-paced environment. Excellent interpersonal skills and ability to work in cross-functional teams and with external vendors. Discretion in handling highly confidential communications. Preferred Skills
Masters Degree or higher in a healthcare field. 7+ years of relevant experience in pharmacovigilance operational activities. Experience with investigator-sponsored trials, extended use programs, and business partnerships. Other Details
The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range is for onsite work and may be adjusted for the local market. Individual pay is determined by factors including job skills, experience, market dynamics, and education. Please note that base salary is part of the total rewards program, including competitive cash compensation, equity awards, benefits, and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination on the basis of race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, medical condition, and veteran status. We respect your privacy and process personal data in accordance with our CCPA Notice and Privacy Policy. For information, please contact privacy@revmed.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Referrals increase your chances of interviewing. Get notified about new Safety Manager jobs in San Francisco Bay Area. #J-18808-Ljbffr