Job Description

Director/Senior Director of Pharmacovigilance (On-site)

Location: Princeton, NJ

Employment Type: Full-Time, Executive Leadership

Reports To: Chief Medical Officer

Position Overview

As the Director of Pharmacovigilance will provide strategic leadership and oversight of all global pharmacovigilance and drug safety operations. This executive will ensure the companys compliance with worldwide safety regulations, guide safety risk management strategies across all product life cycles, and foster a high-performance safety culture. Acting as the primary safety authority for the organization whilst partnering with cross-functional stakeholders to safeguard patients while enabling business objectives.

Key Responsibilities

Strategic Leadership & Governance

• Define and execute the global PV strategy aligned with corporate goals and regulatory expectations.
• Lead the design and continuous improvement of the PV system, ensuring compliance with FDA, EMA, ICH, and other global health authority requirements.
• Serve as the companys senior safety spokesperson in regulatory inspections, audits, and external meetings.
• Chair the Safety Governance Board and oversee all riskbenefit assessments.

Operational Oversight

• Lead PV teams responsible for case processing, signal detection, aggregate reporting, and risk management.
• Ensure timely submission of expedited safety reports, periodic safety update reports (PSURs/PBRERs), and development safety update reports (DSURs).
• Oversee vendor management for outsourced PV activities, ensuring quality and compliance.
• Implement effective pharmacovigilance quality management systems, including SOPs, training, and CAPA processes.

Cross-functional Collaboration

• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to ensure integrated safety strategies.
• Support labeling decisions, safety-related communications, and benefitrisk assessments for regulatory filings.
• Engage with KOLs, regulatory agencies, and industry bodies to represent the companys safety position.

Team Leadership & Development

• Build, inspire, and mentor a high-performing PV organization.
• Foster a culture of operational excellence, scientific rigor, and regulatory compliance.
• Plan and manage PV budgets and resource allocation.

Qualifications & Experience

• MD, PharmD, or equivalent advanced degree in a medical/scientific discipline.
• 15+ years in pharmacovigilance or drug safety, with at least 8 years in senior leadership roles.
• Deep knowledge of global PV regulations (FDA, EMA, ICH E2E, CIOMS).
• Proven experience managing safety across both clinical development and post-marketing environments.
• Exceptional leadership skills with the ability to inspire and manage diverse teams.
• Strong track record of successful regulatory inspections and audits.

Bonus skills:

• Experience in biotech, specialty pharmaceuticals, or immunology/oncology therapeutic areas.
• Board certification in a relevant specialty.
• Previous leadership in a mid-to-large size pharma or biotech organization.

Compensation & Benefits

• Competitive executive-level base salary and performance bonus.
• Long-term equity incentives.
• Comprehensive health, dental, and retirement benefits.
• Relocation assistance (if applicable).

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