Global Drug Safety & PV Operations Leader

Asahi Kasei; United States; A distancia; USD 210.000 - 270.000; Jornada completa

Descripción de la vacante

Asahi Kasei Therapeutics in the United States seeks a Director Global Drug Safety and Pharmacovigilance to lead all product safety activities across the lifecycle, aligning with ICH, FDA, and EMA standards while ensuring inspection readiness.

You will collaborate with Clinical Operations, Medical Affairs, Regulatory, and CROs to shape safety strategy, oversee safety reporting (PSURs, PADERs, DSURs), and manage vendor performance and data exchange.

Formación

• 7+ years of drug safety experience in the pharmaceutical industry.
• Strong knowledge of US and EU pharmacovigilance regulatory requirements.
• Experience with Argus safety database.
• Vendor management and governance experience.
• Excellent leadership and written and verbal communication skills.
• Willingness to travel up to 10%.

Responsabilidades

• Lead the GDSPV strategy and oversee safety activities across product lifecycles.
• Manage pre- and post-marketing safety surveillance in line with ICH, FDA/EMA.
• Provide safety leadership for clinical development and postmarketing programs with cross-functional teams.
• Prepare safety sections for regulatory and scientific documents (ISS, DSURs, PBRERs, NDA/BLA submissions).
• Direct creation/maintenance of Core Safety Information and labeling components.
• Oversee pharmacovigilance reporting and risk management plans (RMPs).
• Manage vendor performance and safety data exchange with CROs and partners.
• Ensure inspection readiness and regulatory compliance.

Conocimientos

Drug safety

Leadership

Regulatory knowledge

Project management

Vendor governance

Communications

MS Office

Educación

Bachelor's degree in scientific/technical field

RN (registered nurse)

Herramientas

Argus

Descripción del empleo

Asahi Kasei Therapeutics in the United States seeks a Director Global Drug Safety and Pharmacovigilance to lead all product safety activities across the lifecycle, aligning with ICH, FDA, and EMA standards while ensuring inspection readiness.

You will collaborate with Clinical Operations, Medical Affairs, Regulatory, and CROs to shape safety strategy, oversee safety reporting (PSURs, PADERs, DSURs), and manage vendor performance and data exchange.