Global Drug Safety & PV Operations Director

Celgard; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Asahi Kasei Therapeutics in the United States seeks a Director Global Drug Safety and Pharmacovigilance (GDSPV) to lead all product safety activities, ensuring compliance with global pharmacovigilance and regulatory requirements. You will align safety strategy with clinical development and postmarketing programs.

The role includes oversight of safety reporting (PSURs, PADERs, DSURs), risk management plans, labeling, vendor governance, and inspection readiness, coordinating with CROs, Medical

Qualifications

• Bachelor’s degree in scientific/technical discipline or equivalent healthcare experience.
• At least 7 years’ drug safety experience in the pharmaceutical industry.
• Strong knowledge of US and EU pharmacovigilance regulatory requirements.
• Experience with safety databases, especially Argus.
• Vendor management/governance experience.
• Excellent leadership and written/verbal communication skills.

Responsibilities

• Lead GDSPV operations and safety strategy.
• Oversee pre- and post-marketing safety surveillance across product lifecycle.
• Provide safety leadership for clinical development and postmarketing programs.
• Contribute to safety sections of regulatory and scientific documents.
• Oversee Safety Information creation and labeling.
• Manage safety reports (DSURs, PSURs, PADERs, DSURs).
• Develop and maintain pharmacovigilance quality systems and audits.

Skills

Leadership

Regulatory knowledge

Pharmacovigilance

Vendor governance

Project management

Communication

MS Office

Education

Bachelor’s degree in scientific/technical discipline

RN or healthcare background

Tools

Argus

Job description

Asahi Kasei Therapeutics in the United States seeks a Director Global Drug Safety and Pharmacovigilance (GDSPV) to lead all product safety activities, ensuring compliance with global pharmacovigilance and regulatory requirements. You will align safety strategy with clinical development and postmarketing programs.

The role includes oversight of safety reporting (PSURs, PADERs, DSURs), risk management plans, labeling, vendor governance, and inspection readiness, coordinating with CROs, Medical