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. Seniority Level Director Employment Type Full‑time Job Function Research Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr EPM Scientific
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