International Pharmacovigilance Excellence Lead, Drug Safety

About This Role:

As the International Pharmacovigilance (IPV) Excellence Lead, you will be at the forefront of ensuring high standards of pharmacovigilance practices across operations globally. Positioned within the IPV team, this role is pivotal in identifying and resolving issues proactively, thereby minimizing risks and enhancing compliance. With a hands-on approach, you'll spearhead continuous improvement initiatives, contributing your expertise as a subject matter expert. Your efforts will be instrumental in optimizing operational efficiency and ensuring compliance, positioning this role as a key driver in our commitment to safety and quality in drug safety practices. You will collaborate with various stakeholders, providing guidance and fostering an environment of shared best practices within the global network.

What You'll Do:

• Contribute to overseeing and updating training materials for case handling procedures to ensure effective global AE collection.
• Coordinate the lifecycle management of IPV controlled documents, including SOPs and R&D Business Processes.
• Implement measures to monitor compliance and enhance quality in local PV procedures and operations.
• Connect with Safety Designated Staff at affiliates to identify and address barriers to execution.
• Present data to leadership, proposing process improvements and training updates.
• Review audit trends, communicate findings, and highlight common risk areas.
• Drive procedural changes with process owners to resolve issues and harmonize IPV processes.
• Collaborate with quality organizations to update on audit observations and remediation plans.
• Support regional and local technology needs harmonization and optimization.
• Ensure optimal use of Affiliate PV Operations Vendors and alignment with global strategies.
• Foster a culture of sharing best practices and innovations within the affiliate network.
• Maintain tools and materials to support affiliate audits and improve efficiency.
• Produce core materials for affiliates to present to local leadership on PV compliance.
• Manage improvement initiatives, collaborating with co-leads and SMEs to drive projects to completion.

• Strong and proven experience in drug safety/pharmacovigilance in a pharmaceutical setting.
• In-depth knowledge of Global, Regional, and Local PV regulations and requirements.
• Excellent written and verbal communication skills.
• Well-developed technical writing and presentation skills.
• Strong project management capabilities.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to work effectively in a fast-paced, matrixed environment.
• Self-starter with strong decision-making and analytical skills.
• Minimum of a bachelor's degree in pharmacy, medicine, or a relevant life science.
• Experience interacting with third parties such as PV operations vendors.
• Knowledge of Good PV Practices.
• Experience with Adverse Events Intake systems and writing procedures.
• Proficiency in English and local language if not native.

• Direct experience in GxP compliant quality systems.
• Experience with audits and regulatory inspections.