Pharmacovigilance Manager
3 weeks ago
We are seeking a highly motivated and experienced individual to fill the role of Manager, Compliance, Training at Sumitomo Pharma America. The successful candidate will be responsible for managing Pharmacovigilance (PVRM) and non-PVRM vendors, ensuring compliance with regulatory requirements and company policies.
Key Responsibilities- Manage PVRM vendors to ensure compliance with contract and statement of work responsibilities
- Develop strategic relationships with vendors to ensure consistent and quality performance
- Liaise with other SMPA departments to ensure non-PVRM vendors meet AE training and reporting requirements
- Manage PVRM reconciliation with internal and external stakeholders
- Work closely with the CTSA Lead to address compliance issues originating with vendors
- Manage annual review and release of companywide Adverse Event (AE) policy training
- Manage PVRM document storage and archiving activities
- Participate in audit and inspection preparation as part of a cross-functional working team
- Conduct routine AE case quality checks and support the IM team with ad-hoc projects
- Bachelor's degree in a scientific, regulatory, or health-related field
- Minimum 6-8 years of relevant experience in the healthcare industry
- Minimum 3 years of experience specific to Pharmacovigilance operations and compliance
- Strong understanding of U.S. regulations and guidance, and a fundamental working knowledge of global regulations and guidance
Sumitomo Pharma America offers a competitive salary range of $124,500 to $156,000, as well as a comprehensive benefits package, including medical, dental, vision, life and disability insurances, and a 401(k) plan. We also offer unlimited paid time off, 11 paid holidays, and 80 hours of paid sick time upon hire and each year thereafter.
We are an equal employment opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced individual looking for a challenging role in Pharmacovigilance and Compliance, please submit your application.
