Senior Director, Pharmacovigilance Scientist

DBV Technologies

2d • $200 - $250 • Hybrid

About The Position

The Senior Director, Pharmacovigilance Scientist drives the development of safety surveillance strategies for assigned programs and indications across the product lifecycle, ensuring compliant, efficient, and high-quality safety surveillance activities in accordance with global regulatory requirements. The role partners closely with cross-functional stakeholders in a fast-paced, growing biotech environment. This position is based in our Warren, New Jersey office on a hybrid schedule (three days in-office per week).

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.

Nice To Haves

• Prior experience in immunology, pediatrics, or related therapeutic areas.
• Experience supporting clinical development safety programs in a biotech setting.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees