Director, Global Drug Safety & Pharmacovigilance Operations

Asahi Kasei • Cary, NC

2d

About The Position

The Director, Global Drug Safety & Pharmacovigilance Operations leads and provides direction for product safety and pharmacovigilance activities in compliance with global pharmacovigilance and regulatory requirements. The role serves as a safety liaison across cross-functional teams and oversees strategic planning and execution for pharmacovigilance, drug safety, case management, and inspection readiness for investigational and marketed products. The Director supports operational excellence and ensures contractual obligations with license partners and vendors are maintained.

The position manages pre- and post-marketing safety surveillance across product life cycles; provides safety leadership and input to clinical development and postmarketing programs; oversees safety documentation, aggregate reports, risk-benefit evaluations, risk management plans, partner agreements, vendors, safety databases, and pharmacovigilance quality systems. It also supports signal detection and safety governance forums, represents the company in safety meetings, manages pharmacovigilance training and budget activities, and maintains knowledge of global regulations. Travel is less than 10%.

Requirements

• Bachelor’s degree in a scientific or technical discipline, RN, or equivalent healthcare experience.
• At least 7 years of drug safety experience in the pharmaceutical industry.
• Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices.
• Solid experience with drug safety databases, especially Argus.
• Solid vendor management and governance experience.
• Self-motivated and detail-oriented, with the ability to prioritize and plan effectively.
• Excellent leadership qualities and written and verbal communication skills.
• Ability to work in a dynamic, fast-paced environment with shifting priorities.
• Experience with internal audits and global regulatory inspections.
• Strong organizational and project management skills.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro.

Responsibilities

• Contribute to the development of GDSPV operations strategy, goals, and objectives, and assist with implementation and training.
• Manage pre- and post-marketing safety surveillance activities throughout product life cycles in compliance with applicable regulations, guidelines, and company procedures.
• Provide pharmacovigilance and drug safety leadership and input for clinical development and postmarketing programs, collaborating with internal and external stakeholders.
• Contribute to preparation and review of safety-related sections in clinical, regulatory, and scientific documents and submissions.
• Direct creation and maintenance of Company Core Safety Information and ensure its implementation in Reference Safety Information and product labeling.
• Oversee preparation of pre- and post-marketing aggregate safety reports for assigned products.
• Oversee risk-benefit evaluations and preparation and review of Risk Management Plans, including risk minimization and effectiveness measures.
• Develop and manage pharmacovigilance activities and safety data exchange agreements with license partners.
• Oversee vendor performance and service outputs, including adverse event and product complaint call-center governance, outsourced case processing, compliance monitoring, aggregate report review, process improvement, and safety database maintenance.
• Develop and maintain the pharmacovigilance quality system and Pharmacovigilance System Master File, as applicable.
• Create and maintain standard operating procedures and working practices to support inspection readiness and regulatory compliance.
• Serve as the pharmacovigilance subject matter expert during internal and external audits and regulatory inspections.
• Manage pharmacovigilance budget and forecasting activities.
• Support signal detection, safety risk assessment, and communication of safety assessments in collaboration with relevant team members.
• Support and participate in Safety Management Team, Benefit Risk Assessment Team, and other product safety forums.
• Represent the company in product safety meetings with license partners and CROs.
• Provide pharmacovigilance training to company personnel and manage training compliance.
• Maintain current knowledge of global regulations and regulatory guidelines.
• Perform other drug safety and pharmacovigilance activities appropriate to experience and expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Director