Director, Global Drug Safety – Pharmacovigilance Operations

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Lead and offer guidance for all product safety and pharmacovigilance functions in adherence to global standards.

• Formulate the GDSPV operations strategy, including goals, objectives, implementation plans, and training initiatives.

• Oversee pre- and post-marketing safety monitoring activities throughout the lifecycle of products.

• Provide leadership in pharmacovigilance for clinical development and post-marketing programs while partnering with both internal and external stakeholders.

• Prepare and evaluate safety sections of clinical, regulatory, and scientific documents and submissions.

• Direct the development and upkeep of Core Safety Information and Reference Safety Information.

• Supervise the preparation of aggregate safety reports, such as PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and SUSAR line listings.

• Manage risk-benefit assessments and create Risk Management Plans.

• Develop and oversee pharmacovigilance activities and safety data exchange agreements with licensing partners.

• Govern vendors, which includes overseeing adverse event/product complaint call centers, outsourced ICSR processing, monitoring reports, and safety database operations.

• Establish and maintain the pharmacovigilance quality system and the Pharmacovigilance System Master File.

• Create and uphold SOPs and operational practices to ensure readiness for inspections and compliance with regulations.

• Act as the pharmacovigilance subject matter expert during audits and regulatory inspections.

• Manage the pharmacovigilance budget and forecasting activities.

• Support signal detection, safety evaluations, and meetings for the Safety Management Team and Benefit Risk Assessment Team.

• Represent the company in product safety discussions with licensing partners and CROs.

• Provide pharmacovigilance training and oversee training compliance.

• Stay updated on global regulations and guidelines.

⛳️ Requirements

• Bachelor’s degree in a scientific or technical field, RN, or equivalent healthcare experience.

• Minimum of 7 years of drug safety experience within the pharmaceutical industry.

• Comprehensive understanding of US and EU pharmacovigilance regulatory requirements and contemporary practices.

• Extensive experience with drug safety databases, particularly with Argus.

• Strong background in vendor management and governance.

• Self-driven, detail-oriented, and capable of prioritizing and planning effectively.

• Excellent leadership abilities along with strong written and verbal communication skills.

• Ability to thrive in a dynamic, fast-paced environment with changing priorities.

• Experience in conducting internal audits and managing global regulatory inspections.

• Robust organizational and project management capabilities.

• Proficient in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro.

• Travel Requirements: <10%.

🏝️ Benefits

• Equal opportunity employer dedicated to fostering a diverse workforce.

• Flexible remote work arrangements available.

• Travel requirements: <10%.