Senior Manager, CTSA, PVRM
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $155,000 - $193,000 per year
Job Level
About the role
- Lead strategic relationships with PVRM and non-PVRM vendors
- Provide strategic oversight of adverse event (AE) management and reporting processes
- Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality
- Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits
- Develop and maintain PV staff learning plans, manage compliance activities
- Oversee development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems
- Support global safety planning and coordination, maintain relationships with business partners, affiliates, and subsidiaries
- Provide expert support for Pharmacovigilance Agreements (PVAs)
- Mentor and coach team members
Requirements
- Bachelor's degree required; preferably in a scientific, regulatory, or health-related field; advanced degree preferred
- Minimum 8 – 10 years of relevant experience in healthcare industry
- Minimum 5 years of experience specific to Pharmacovigilance operations and compliance
- Project leadership/management skills
- Excellent understanding of U.S. regulations and guidances, and a strong working knowledge of global regulations and guidances such as European Economic Area, United Kingdom, and Canadian regulatory frameworks
Benefits
- Medical, dental, vision, life and disability insurances
- 401(k) plan participation
- Merit-based salary increases
- Short incentive plan participation
- Flexible paid time off
- 11 paid holidays
- Additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Pharmacovigilance operationsadverse event managementaudit and inspection preparednesscompliance activitiesstandard operating proceduresglobal safety planningPharmacovigilance Agreements
Soft skills
project leadershipteam mentoringcollaborationstrategic oversight
Certifications
Bachelor's degreeadvanced degree