Senior Manager, PVRM
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $151,840 - $189,800 per year
Job Level
Senior
About the role
- Lead cross-functional Safety Management Team (SMT) meetings to assess drug safety policies
- Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information
- Maintain ongoing monitoring and updates of safety profiles for assigned investigational and marketed products
- Collaborate with colleagues in Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other departments
- Review adverse event reports to ensure appropriate interpretation, consistency, and quality
- Serve as SME in study protocol design
- Support preparation and presentation of individual case safety report issues
- Contribute to the development and maintenance of internal safety documents
Requirements
- Minimum 4–7+ years of relevant pharmacovigilance or drug safety experience in the biotechnology or pharmaceutical industry
- prior leadership or project management experience strongly preferred
- Strong understanding of global drug safety dynamics
- hands-on experience in risk mitigation strategies preferred
- Experience preparing safety reports and submissions to FDA, EMA, and/or other regulatory authorities
- Effective working skills in a cross-functional, matrixed environment
- Excellent verbal and written communication skills.
- Demonstrated ability to work independently, prioritize across multiple projects, and deliver with minimal supervision.
Benefits
- merit-based salary increases
- short incentive plan participation
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances
- robust time-off policy including flexible paid time off and 11 paid holidays
- additional time off for shutdown 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
pharmacovigilancedrug safetysignal detectionrisk mitigation strategiessafety report preparationFDA submissionsEMA submissionsstudy protocol designadverse event report reviewsafety profile monitoring
Soft skills
leadershipproject managementcommunicationindependenceprioritizationcollaborationcross-functional teamworkorganizational skillsproblem-solvingadaptability