Director, Global Drug Safety & PV Operations

Asahi Kasei Bioprocess America, Inc.; Cary (NC); On-site; USD 130,000 - 170,000; Full time

Job summary

Asahi Kasei Bioprocess America, Inc. is hiring a Director of Global Drug Safety and Pharmacovigilance Operations.

You will lead safety strategy and oversee global pharmacovigilance activities across product life cycles, collaborating with cross-functional teams to ensure compliance with ICH, FDA, and EMA requirements. The role requires strong leadership, risk management, and experience with safety databases and regulatory inspections.

Qualifications

• Bachelor’s degree in scientific/technical discipline.
• At least 7 years’ drug safety experience in the pharmaceutical industry.
• Strong knowledge of US/EU pharmacovigilance regulatory requirements and current practices.
• Experience with drug safety databases, especially Argus.
• Vendor management/governance experience.
• Excellent leadership and communication skills.
• Ability to work in a dynamic, fast-paced environment with shifting priorities.

Responsibilities

• Lead and direct pharmacovigilance operations and safety strategy for GDSPV.
• Oversee pre- and post-marketing safety surveillance across product life cycles.
• Provide safety leadership for clinical development and postmarketing programs.
• Prepare and review safety sections of regulatory documents and labeling.
• Oversee PKSI/RSI, CCSI, and CDDS alignment for labeling and safety information.
• Manage vendor performance, safety data exchange, and safety database systems.
• Support inspections, audits, and safety signal management.

Skills

PV leadership

FDA/EMA regulatory

ICH guidelines

PV systems

Vendor management

Clinical safety oversight

Regulatory inspections

Education

Bachelor’s degree in scientific/technical discipline

Tools

Argus

MS Office

Adobe Pro

Job description

Asahi Kasei Bioprocess America, Inc. is hiring a Director of Global Drug Safety and Pharmacovigilance Operations.

You will lead safety strategy and oversee global pharmacovigilance activities across product life cycles, collaborating with cross-functional teams to ensure compliance with ICH, FDA, and EMA requirements. The role requires strong leadership, risk management, and experience with safety databases and regulatory inspections.