Senior Manager, Global Patient Safety Operations

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 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
• Able to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives
• Able 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

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.

Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

Represents Global Patient Safety in different cross functional team meetings.

Collaborates with other functional groups to achieve clinical program goals.

Oversees Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

Manages PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

Oversees reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

Ensures timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

Supports authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

Supports the execution and maintenance Safety Data Exchange Agreements /Pharmacovigilance Agreements with business partners.

Collaborates with other functional groups in SAE reconciliation and SAE query resolution activities.

Supports 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).

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $164,000 - $205,000 USD.