Director - Global Pharmacovigilance and Risk Management

January 30

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Finding the specialized talent that drives top Life Sciences organizations takes more than job board posts.

Diagnostic Imaging & AI • Cell & Gene Therapy • Biotechnology • Pharmaceutical • Medical Device

11 - 50 employees

📋 Description

• Oversee and manage the processing, review and submission of all individual case safety reports to ensure high quality and compliance. • Oversee and manage the global literature search. • Manage and develop Global team. • Coordinate with external vendor and internal medical personnel as needed. • Provides oversight and support for external safety data processing provider, ensuring efficient and cost-effective services. • Coordinates product safety oversight activities. • Assist team and senior management in all forms of safety issue management and mitigation. • Analyze metrics for critical department processes to ensure compliance with SOPs and regulatory requirements. • Formulate and implement improvements and enhancements as needed, including procedural and technical advancements. • Represent GPRM in key internal departments interactions including Regulatory Affairs, Clinical R&D, Quality Assurance and Medical Communications. • Inform Risk Management department when aware of any safety-related issues and potential trends and/or signals arising from review of post-marketed safety data. • Manage PV CAPA related to case processing, submission and literature search. • Support integration activities related to acquisitions, mergers and divestments of products. • Answer questions from authorities related to vigilance. • Participate in audits and inspections. • Ensure business continuity of processes. • Maintain current knowledge of global pharmacovigilance regulations and requirements.

🎯 Requirements

• Global safety and pharmacovigilance regulations and guidelines • Use of safety database, preferably ARISg • Working knowledge of scientific terms and medical terminology including proficiency with MedDRA and WHODrug use and administration • Excellent oral and written communication skills • Excellent interpersonal skills and willingness to work in a team environment • Ability to utilize and develop available human and technical resources • Demonstrates consistent attention to detail • Highly organized and demonstrates understanding of workflow prioritization and resource allocation