Senior Director, Pharmacovigilance Operations
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
- 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.
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.
- Prior experience in immunology, pediatrics, or related therapeutic areas.
- Experience supporting clinical development 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
pharmacovigilancecase processingregulatory reportingsafety database managementKPI monitoringquality metricsSOP developmentoperational processessafety reportinginspection readiness
Soft Skills
leadershipcommunicationcross-functional collaborationmentoringstrategic thinkingindependenceorganizational skillsproblem-solvingteam developmentrelationship management
Certifications
Bachelor's degree in PharmacyBachelor's degree in NursingMSPharmDPhD