Senior Director, Head of Safety Science – Pharmacovigilance
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $275,000 - $300,000 per year
Job Level
About the role
- Reporting to the SVP, Drug Safety and Pharmacovigilance, the Senior Director is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products.
- Oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent’s products.
- Close collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management.
- Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Assist in the evaluation of potential safety issues and quality risk assessment reports.
- Coordinate and develop Risk Management Plans for Nuvalent’s products among multiple stakeholders.
- Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in close collaboration with clinical, medical writing and operational functions.
Requirements
- Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
- 9+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical, biotech company or regulatory agency in similar positions
- Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
- Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
- Experience with safety data collection and interpretation from clinical trials, literature and post market
- Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
- Experience with the development and updates to Reference Safety Information, IB, Company Core Data Sheet and local labels
- Excellent verbal, written and presentation skills.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
- comprehensive benefit package to support employees
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk managementsignal detectionsignal evaluationdrug safety assessmentssafety data collectionIND submissionsNDA submissionsReference Safety InformationCompany Core Data Sheetaggregate safety reports
Soft Skills
collaborationanalytical skillscommunicationpresentation skillsproblem-solving
Certifications
MDPharmDRNPhD