Vice President Pharmacovigilance

Avetix Bio; United States; Sur place; USD 150 000 - 200 000; Plein temps

Résumé du poste

A leading biotech company in the United States seeks a VP, Patient Safety & Pharmacovigilance. This strategic role involves leading the global pharmacovigilance system and ensuring compliance with regulatory standards while managing risk and safety across product lifecycles. The ideal candidate will have an M.D. and 12–15+ years of relevant experience. You will collaborate closely with multiple departments and external vendors to achieve excellence in safety governance and execution.

Qualifications

• 12–15+ years of pharmacovigilance or drug safety experience in biotech or pharma.
• Proven experience building or scaling global PV systems.
• Strong knowledge of FDA, EMA, ICH, and GVP requirements.

Responsabilités

• Establish and maintain a compliant, scalable global PV system.
• Lead safety strategy, risk management plans, signal detection.
• Manage and oversee external PV vendors for quality and compliance.

Connaissances

Pharmacovigilance experience

Regulatory compliance

Risk management

Leadership in cross-functional environments

Effective communication

Formation

M.D.

Description du poste

The VP, Patient Safety & Pharmacovigilance will lead the strategy, build-out, and oversight of the global pharmacovigilance system, ensuring regulatory compliance and a proactive, risk-based approach to patient safety across the product lifecycle. This role partners closely with Clinical Development, Regulatory Affairs, Quality, and external vendors to deliver best-in-class safety governance and execution.

Key Responsibilities

• Establish and maintain a compliant, scalable global PV system, including SOPs, workflows, and safety governance.
• Lead safety strategy, risk management plans, signal detection, and benefit–risk assessments across development programs.
• Manage and oversee external PV vendors, ensuring quality, compliance, and budget adherence.
• Lead safety contributions to regulatory submissions and responses to health authority queries.
• Ensure timely expedited and aggregate safety reporting (DSURs, PSURs, PADERs).
• Chair internal safety review committees and maintain inspection and audit readiness.

Qualifications

• M.D.
• 12–15+ years of pharmacovigilance or drug safety experience in biotech or pharma.
• Proven experience building or scaling global PV systems.
• Strong knowledge of FDA, EMA, ICH, and GVP requirements.
• Demonstrated leadership in cross-functional and vendor‑managed environments.

Leadership Profile

• Strategic, collaborative leader with strong operational rigor.
• Clear communicator able to translate complex safety data into actionable insights.
• High integrity, sound judgment, and a patient-first mindset.