Global Pharmacovigilance & Drug Safety Director

Asahi Kasei Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Asahi Kasei Therapeutics in the United States seeks a senior Pharmacovigilance leader to guide safety surveillance across lifecycle, ensure compliance with ICH, FDA/EMA, and GVP, and drive high-quality safety data handling.

You will manage vendor performance, lead safety documentation, and coordinate cross-functional teams in Clinical Operations, Regulatory Affairs, and CROs to support product safety excellence.

Qualifications

• Bachelor’s degree in scientific/technical discipline, RN, 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 drug safety databases, especially Argus.
• Vendor governance and management experience.
• Excellent leadership, communication, and project management skills.
• Ability to work in a dynamic, fast-paced environment with shifting priorities.

Responsibilities

• Develop and oversee pharmacovigilance activities and safety data handling across lifecycle.
• Coordinate safety surveillance in compliance with ICH, FDA/EMA, and GVP.
• Lead preparation of safety documents and regulatory submissions.
• Manage vendor relationships and ensure timely, within-budget outputs.
• Represent PV team in audits and regulatory inspections.
• Support SMT/BRAT meetings and safety communications.

Skills

Drug safety leadership

Regulatory knowledge

Vendor governance

Project management

Communication

Attention to detail

Team leadership

Process improvement

Prioritization

Adaptability

Education

Bachelor’s degree in scientific/technical discipline or RN

Tools

Argus pharmacovigilance database

MS Office

Adobe Pro

Job description

Asahi Kasei Therapeutics in the United States seeks a senior Pharmacovigilance leader to guide safety surveillance across lifecycle, ensure compliance with ICH, FDA/EMA, and GVP, and drive high-quality safety data handling.

You will manage vendor performance, lead safety documentation, and coordinate cross-functional teams in Clinical Operations, Regulatory Affairs, and CROs to support product safety excellence.