Senior Director, Global Drug Safety & PV Physician

Genmab; Princeton (NJ); Sur place; USD 236 000 - 354 000; Plein temps

Avantages offerts par ce poste

401(k) Plan: 100% match on first 6%

Health benefits

Dental & vision insurance

Paid vacation & holidays

Parental leave

Résumé du poste

Genmab is seeking an experienced Director of Drug Safety & Pharmacovigilance to lead global safety strategy for its products. You will engage cross-functionally at all levels, interact with regulatory authorities, and mentor junior colleagues while ensuring robust safety signals review and risk management across the product lifecycle.

You will contribute to safety reporting, regulatory submissions, and training across Genmab's international sites in a fast-paced, dynamic environment.

Qualifications

• MD required and licensed to practice medicine.
• Minimum 12+ years in drug safety/pharmacovigilance in oncology.
• Experience with FDA interactions and regulatory submissions (BLA/NDA).
• Experience with global PV regulations and safety databases.

Responsabilités

• Lead major safety activities including signal, risk management and benefit-risk evaluation.
• Collaborate with cross-functional teams for safety assessments and reporting.
• Oversee safety issue handling and implement risk mitigation strategies.
• Prepare safety documentation per regulatory requirements and contribute to reports.
• Mentor junior staff and train stakeholders on PV processes.

Formation

MD degree in Medicine

Outils

ARISg

ARGUS

WHODrug

Description du poste

Genmab is seeking an experienced Director of Drug Safety & Pharmacovigilance to lead global safety strategy for its products. You will engage cross-functionally at all levels, interact with regulatory authorities, and mentor junior colleagues while ensuring robust safety signals review and risk management across the product lifecycle.

You will contribute to safety reporting, regulatory submissions, and training across Genmab's international sites in a fast-paced, dynamic environment.