Pharmacovigilance Director - Europe
October 30
Description
• Luminary Group is in search of an experienced and strategic Pharmacovigilance Director to join our client in Europe. • In this leadership role, you will oversee the pharmacovigilance functions and ensure compliance with regulatory standards, while leading initiatives to enhance product safety and maintain high-quality standards. • Develop and implement the pharmacovigilance strategy for the region in accordance with regulatory requirements and industry standards. • Lead and manage the pharmacovigilance team, ensuring high performance and professional development. • Oversee the processing and evaluation of safety reports and adverse events for all products. • Conduct signal detection, risk assessments, and safety evaluations to identify potential safety issues. • Collaborate with cross-functional teams to ensure timely and accurate reporting of safety information to regulatory authorities. • Serve as the primary point of contact for regulatory authorities during inspections and audits. • Ensure compliance with pharmacovigilance regulations and internal policies, and facilitate continuous improvement initiatives. • Stay updated with the latest regulatory changes and best practices in pharmacovigilance.
Requirements
• Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences, or a related field. • Minimum of 8 years of experience in pharmacovigilance, with at least 3 years in a leadership role. • Strong knowledge of pharmacovigilance regulations and guidance in Europe. • Proven experience in managing teams and leading cross-functional projects. • Expertise in signal detection, risk management, and safety reporting processes. • Excellent communication and interpersonal skills, capable of building relationships with internal and external stakeholders. • Strong analytical and critical thinking skills. • Ability to work independently and make strategic decisions. • Proficiency in using pharmacovigilance databases and safety reporting systems. • Willingness to travel as needed for meetings and inspections.
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