Global PV Director & Drug Safety Physician

Jobtome; Ada (OK); Presencial; USD 236.000 - 354.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) match

Health benefits

Voluntary plans

Paid time off

Support resources

Perks

Descripción de la vacante

Genmab is seeking an experienced Director, GDS & PV Physician to lead global drug safety activities and shape the safety profile across product lifecycles. The role requires broad cross-functional engagement, regulatory liaison, and a focus on education and mentorship within a highly skilled team.

You will drive safety assessments, oversee risk management, and contribute to regulatory submissions while partnering with external authorities and internal stakeholders worldwide.

Formación

• MD required with clinical pharmacovigilance background.
• 12+ years of drug safety/pharmacovigilance in clinical development and post‑marketing.
• Experience with BLA/NDA submission and regulatory inspections (FDA and others).
• Experience with global PV regulations, MedDRA/WHODrug, and adverse event processing.

Responsabilidades

• Lead pre- and post-marketing safety activities including signal and risk management.
• Collaborate with cross-functional teams for safety assessment and literature review.
• Oversee safety issue handling and propose systemic mitigation.
• Contribute to trial documents and safety sections of reports.
• Manage safety forums and provide guidance on PV processes.
• Mentor and train teams on evolving PV concepts and regulations.

Conocimientos

Medical degree

Drug safety

Pharmacovigilance

Regulatory knowledge

Mentoring / leadership

Cross-functional collaboration

Educación

MD

Herramientas

ARISg

ARGUS

PV databases

Descripción del empleo

Genmab is seeking an experienced Director, GDS & PV Physician to lead global drug safety activities and shape the safety profile across product lifecycles. The role requires broad cross-functional engagement, regulatory liaison, and a focus on education and mentorship within a highly skilled team.

You will drive safety assessments, oversee risk management, and contribute to regulatory submissions while partnering with external authorities and internal stakeholders worldwide.