Global Head of Pharmacovigilance & Risk Management

Regulatory Jobs; New Jersey; Sur place; USD 309 000 - 401 000; Plein temps

Résumé du poste

Celldex is seeking a Senior leader for Pharmacovigilance & Risk Management to drive the global safety strategy across clinical and planned commercial programs. You will oversee surveillance, risk management, and regulatory submissions, partnering with Clinical Development, Regulatory Affairs, and Quality to ensure proactive safety governance.

Ideal candidates bring 15+ years in pharma/biotech pharmacovigilance, MD qualification, and a track record of leading scalable safety organizations in

Qualifications

• 15+ years of experience in pharma/biotech with leadership in pharmacovigilance.
• Deep expertise in global pharmacovigilance regulations, safety surveillance, and risk management.
• Experience supporting late-stage development programs, regulatory submissions, and/or product launches.
• Proven ability to lead and scale pharmacovigilance organizations within a growing biotech or pharma company.
• Strong scientific and clinical acumen with the ability to synthesize and communicate complex safety information.
• Demonstrated success working cross-functionally and influencing within matrixed organizations.
• Excellent leadership, communication, and stakeholder management skills; thrives in a fast-paced, entrepreneurial environment.

Responsabilités

• Provide strategic leadership for the global Pharmacovigilance and Risk Management function.
• Develop and execute the company’s global safety strategy across clinical and future commercial programs.
• Lead the evolution of pharmacovigilance infrastructure, systems, processes, and governance.
• Serve as the senior safety advisor to executive leadership and cross-functional teams.
• Oversee safety submissions and responses to global health authorities.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, Quality, and Commercial on safety strategy.

Connaissances

Leadership

Global pharmacovigilance

Drug safety

Regulatory knowledge

Cross-functional collaboration

Strategic thinking

Formation

MD

Outils

Safety systems

Description du poste

Celldex is seeking a Senior leader for Pharmacovigilance & Risk Management to drive the global safety strategy across clinical and planned commercial programs. You will oversee surveillance, risk management, and regulatory submissions, partnering with Clinical Development, Regulatory Affairs, and Quality to ensure proactive safety governance.

Ideal candidates bring 15+ years in pharma/biotech pharmacovigilance, MD qualification, and a track record of leading scalable safety organizations in