Director, Global Drug Safety & Pharmacovigilance Operations

Celgard • Cary, NC

1d

About The Position

The Director of Global Drug Safety and Pharmacovigilance (GDSPV) 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 with cross-functional teams and oversees strategic planning and execution of pharmacovigilance, drug safety, case management, and inspection readiness for investigational and marketed products. It also supports operational excellence and ensures that contractual obligations with license partners and vendors are maintained.

The position contributes to GDSPV strategy, goals, and objectives, and manages pre- and post-marketing safety surveillance throughout product lifecycles. It provides safety leadership and input across clinical development and postmarketing programs, prepares and reviews safety content in clinical and regulatory documents, directs core safety information and product labeling, and oversees aggregate safety reporting and risk-benefit evaluations. The Director also governs vendors and safety systems, maintains the pharmacovigilance quality system and documentation, supports signal detection and safety committees, manages the pharmacovigilance budget, trains company personnel, and maintains current 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.
• Travel requirement of less than 10%.

Responsibilities

• Contribute to GDSPV operations strategy, goals, and objectives, and assist with implementation and training.
• Manage pre- and post-marketing safety surveillance for company products throughout their lifecycles in compliance with applicable regulations, guidelines, and company procedures.
• Provide pharmacovigilance and drug safety leadership for clinical development and postmarketing programs, collaborating with internal and external stakeholders.
• Contribute to preparation and review of safety sections in clinical, regulatory, and scientific documents.
• 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.
• Develop and manage pharmacovigilance activities and safety data exchange agreements with license partners.
• Manage vendor performance and service outputs, including AE/product complaint call center governance, outsourced ICSR processing, monitoring and KPIs, aggregate report reviews, process improvement, and safety database oversight.
• Develop and maintain the pharmacovigilance quality system.
• Contribute to development and maintenance of the Pharmacovigilance System Master File as applicable.
• Create and maintain SOPs and working practices to support inspection readiness and regulatory compliance.
• Serve as the company pharmacovigilance subject matter expert during internal and external audits and regulatory inspections.
• Manage pharmacovigilance budgets and forecasting.
• Support signal detection, evaluation, validation, and communication of safety assessments in collaboration with relevant team members.
• Support and participate in Safety Management Team, Benefit Risk Assessment Team, and other forum meetings.
• Represent the company in product safety meetings with license partners and CROs.
• Provide pharmacovigilance compliance 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