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 Range : 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.