Director – Packaging Technology
Sanofi
Director, Pharmacovigilance Scientist
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Serve as the PV lead for assigned programs, accountable for end-to-end safety deliverables including signal detection, aggregate reporting, and risk management planning.
- Represent PV on program-level governance committees and cross-functional teams, ensuring clear role delineation between PV and Clinical Development.
- Lead the preparation and PV input into protocols, Investigator Brochures, ICFs, SAPs, CSRs, regulatory submissions, and labeling documents for assigned programs.
- Develop and maintain program-level PV strategies aligned with global regulatory requirements and company objectives.
- Lead PV contributions to regulatory authority interactions and inspection readiness activities for assigned programs.
- Partner with CROs and vendors to ensure timely and compliant PV deliverables; monitor performance and escalate issues as needed.
- Contribute to departmental process improvement and knowledge-sharing initiatives.
- Mentor junior staff or consultants supporting PV deliverables.
Requirements
- Advanced degree in Pharmacy, Nursing, Epidemiology, Biosciences, or related healthcare discipline.
- 8+ years of pharmaceutical industry experience, with at least 6 years in pharmacovigilance.
- Demonstrated experience as the PV lead for global clinical programs across multiple phases.
- Strong expertise in safety data evaluation, signal detection, aggregate reporting, and regulatory submissions.
- Proven ability to represent PV in cross-functional and external regulatory settings.
- Experience collaborating with and influencing senior cross-functional stakeholders in a matrix environment.
- Excellent communication, organizational, and leadership skills.
- Ability to manage competing priorities in a fast-paced, dynamic environment.
Benefits
- Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancesignal detectionaggregate reportingrisk management planningregulatory submissionssafety data evaluationprotocol preparationinvestigator brochuresICFsCSRs
Soft skills
communicationorganizationalleadershipmentoringcollaborationinfluencingproblem-solvingtime managementadaptabilitystakeholder engagement