Director Pharmacovigilance

Pharmacovigilance Director

Northern New Jersey

Compensation: $240,000-260,000 Bonus Equity

An industry-leading biotech with a proprietary discovery platform and a proven leadership team behind one of the most transformative immuno-oncology approvals is looking for a Pharmacovigilance Director. The company boasts a robust pipeline with multiple late-stage programs and over 10 additional indications, spanning oncology, neurology, and immunology. Backed by top-tier investors and a multi-year cash runway, they are well-positioned for rapid growth and significant impact.

Key Responsibilities

• Lead Pharmacovigilance Strategy: Drive the overall safety vision and execution, ensuring robust processes for monitoring, evaluating, and reporting adverse events across the portfolio.
• Global Safety Reporting: Oversee timely, compliant submissions of safety data to health authorities in alignment with international regulations.
• Case Management Expertise: Manage end-to-end case handling, including data entry, quality review, medical assessment, and approval of serious and special interest cases (SAEs, AESIs, SUSARs).
• Signal Detection & Risk Assessment: Partner with clinical safety teams to analyze safety data, identify emerging risks, and shape mitigation strategies.
• Quality & Compliance Oversight: Uphold rigorous standards for PV operations, ensuring adherence to internal SOPs and regulatory expectations.
• Vendor Partnership: Provide governance and oversight for external PV service providers, maintaining strong collaboration and performance.
• Training & Knowledge Sharing: Deliver safety-related education to internal teams, fostering a culture of compliance and patient protection.
• Documentation Excellence: Ensure accurate, complete, and audit-ready PV records and reports.
• Regulatory Vigilance: Monitor evolving global safety requirements and implement necessary updates to maintain compliance.
• Cross-Functional Integration: Work closely with clinical, regulatory, and other stakeholders to align PV activities with program objectives and timelines.

Ideal Candidate

• Medical degree (MD) with 6 years in pharmacovigilance or drug safety.
• Hands-on experience in case processing, medical review, narrative authoring, aggregate reporting, SOP development, and vendor oversight.
• Proven leadership and team management capabilities.