Senior Manager, Global Patient Safety Operations
- Redwood City, CA
- $145,600-166,400 per year
- Permanent
- Full-time
- Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.
- 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 that resolution is achieved in a timely manner.
- 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 the Safety Data Exchange Agreements.
- Pharmacovigilance Agreements with business partners.
- Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.
- Support the 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).
- 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, multitask, prioritize options, work independently, anticipate challenges, and execute assigned deliverables.
- Ability to analyze situations and data that require 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 the ability to work in cross-functional team environments and with external vendors
- Exercise discretion regarding highly confidential internal and external communications
- 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