Senior Director, Pharmacovigilance Scientist
DBV Technologies
full-time
Posted on:
Location Type: Hybrid
Location: Warren • New Jersey • United States
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Salary
💰 $200,000 - $250,000 per year
Job Level
About the role
- Represent the PV function in cross-functional projects and teams, partnering with Drug Safety Physicians to develop safety surveillance strategies and contribute to benefit-risk assessments for assigned products.
- Support the evaluation and management of safety signals from all data sources, including signal detection, benefit-risk profile assessment, and aggregate reporting activities.
- Oversee, prepare, and/or review safety documents including periodic safety reports (PSURs/PBRERs), DSURs, signal evaluation reports, risk management plans, and other safety-related documents.
- Formulate and contribute to responses to health authority inquiries related to product safety.
- Partner with the Clinical team to support safety management plans and medical monitoring strategies for clinical programs.
Requirements
- Bachelor's degree in, Pharmacy, Medicine or related healthcare professional field required; advanced degree (MS, PharmD, PhD, MD) preferred.
- Minimum 12 years of experience in pharmacovigilance within the biopharmaceutical industry.
- At least 8 years of experience in signal detection and safety surveillance activities.
- Proficiency with safety surveillance tools and safety databases (e.g., Empirica Signal, LifeSphere Advanced Signals, AEMS, EVDAS).
- Experience building or scaling PV signal detection processes in a growing organization.
- Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, Health Canada, EMA, ICH).
- Excellent communication, leadership, and cross-functional collaboration skills.
- Ability to operate independently and strategically in a small, evolving organization.
- Prior experience in immunology, pediatrics, or related therapeutic areas.
- Experience supporting clinical development safety programs in a biotech setting.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesignal detectionsafety surveillancebenefit-risk assessmentsafety document preparationrisk management plansclinical program supportsafety management plansmedical monitoring strategies
Soft Skills
communicationleadershipcross-functional collaborationindependent operationstrategic thinking
Certifications
Bachelor's degreeMSPharmDPhDMD