Senior Director, Pharmacovigilance Operations

Description

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).

Location

Warren, New Jersey - 3 days on site & 2 days remote

Salary

200-250K

Key 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.

Qualifications

• 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.

Behavioral Skills

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions.
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals.
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

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