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.
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