Director/Senior Director of Pharmacovigilance Director/Senior Director of Pharmacovigilance 1 day ago Be among the first 25 applicants Director/Senior Director of Pharmacovigilance (On-site) 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. 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. 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. Competitive executive-level base salary and performance bonus. Long-term equity incentives. Relocation assistance (if applicable). Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Research Industries Pharmaceutical Manufacturing, Biotechnology Research, and Health and Human Services Referrals increase your chances of interviewing at Vivid Resourcing by 2x Get notified about new Director Clinical Research jobs in Raleigh-Durham-Chapel Hill Area . Durham, NC $255,990.00-$299,881.00 2 weeks ago Raleigh-Durham-Chapel Hill Area 1 day ago Director, Francis Owen Blood Research Laboratory Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modelling and Simulation Medical or Senior Medical Director - Ophthalmology US REMOTE based Durham, NC $250,000.00-$350,000.00 2 weeks ago Senior Medical Director ( Endocrinology) - U.S. - Remote Director Clinical Practice and Education, Duke Cancer Network Director, Medical Economics (Primarily Remote, North Carolina Based) Morrisville, NC $116,926.00-$149,080.00 1 month ago Assistant Director, Clinical Trials Quality Assurance Program Raleigh, NC $50,000.00-$400,000.00 3 days ago Medical Director, Transplant and Immunology Apex, NC $195,500.00-$212,000.00 1 week ago Director Advanced Analytics and AI - Shockwave Medical Raleigh, NC $160,000.00-$317,400.00 2 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Vivid Resourcing
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