Senior Director, Pharmacovigilance Operations

DBV Technologies

2d•$200 - $250•Hybrid

About The Position

The Senior Director of Pharmacovigilance (PV) Operations provides strategic and operational leadership for pharmacovigilance activities across the product lifecycle, ensuring compliant, efficient, and high-quality safety operations 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, Nursing or a related healthcare professional field required; advanced degree (MS, PharmD, PhD) preferred.
Minimum 12 years of experience in pharmacovigilance within the biopharmaceutical industry.
At least 5 years of leadership or management experience overseeing PV operations and/or vendors.
Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, Health Canada, EMA, ICH).
Proficiency with safety databases (e.g., Argus, ArisG), case processing workflows, and regulatory safety reporting.
Experience building or scaling PV operational processes in a growing organization.
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 programs in a biotech setting.

Responsibilities

Lead and oversee all PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs, MDRs) and lead aggregate safety reporting activities (e.g., DSURs, PSURs/PBRERs).
Manage PV vendor relationships, including case processing and safety database vendors; establish and monitor KPIs, quality metrics, and service performance.
Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.
Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, Health Canada, EMA, ICH, and global PV regulations.
Serve as the primary PV Operations interface with Medical Affairs, Clinical Development, Regulatory Affairs, Quality, and external partners.
Lead and/or contribute to safety governance activities and committees.
Drive inspection and audit readiness, including supporting the hosting of health authority inspections.
Serve as a key contributor to health authority inquiry responses and interactions.
Mentor and develop PV Operations staff and contribute to the growth and scaling of the pharmacovigilance function.