Senior Director, Pharmacovigilance Operations

DBV Technologies

Senior Director of Pharmacovigilance Operations providing leadership for PV activities in a biotech environment. Overseeing safety operations and ensuring compliance with regulatory requirements.

Posted 4/14/2026full-timeWarren • New Jersey • 🇺🇸 United StatesSenior💰 $200,000 - $250,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide Post a Job Affiliates ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs Account DBV Technologies Website LinkedIn All Job Openings 51 - 200 employees 🧬 Biotechnology 💊 Pharmaceuticals 🔥 Funding within the last year 💰 $30M Post-IPO Secondary - DBV Technologies on 2025-10 Biotechnology
Pharmaceuticals DBV Technologies is a global clinical-stage biopharmaceutical company developing epicutaneous immunotherapy to treat food allergies and other immune-mediated diseases. Founded by pediatricians, the company is advancing its proprietary VIASKIN® patch technology through clinical trials—including Phase 3 studies for a peanut allergy patch (DBV712) and earlier-stage programs for milk allergy (DBV135)—with the goal of re-educating the immune system using controlled skin exposure to antigens. Senior Director, Pharmacovigilance Operations 🔥 2 minutes ago 🏢🏡 Warren – Hybrid 💵 $200k - $250k / year ⏰ Full Time 🟠 Senior ⚙️ Operations Apply Now Find Hiring Managers Customize resume for this job ☆ Save ☑️ Mark as applied ❌ Hide Report problem 📋 Description
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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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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