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Pharmacovigilance Director
2 weeks ago
**About Us**
Regeneron Ireland DAC is a leading pharmaceutical company dedicated to discovering and developing innovative treatments for serious medical conditions.
We are seeking an experienced professional to join our team as an Associate Director in GPS Standards & Training, where you will play a critical role in maintaining the Pharmacovigilance (PV) Quality Management System.
This position requires a self-motivated individual who can drive projects independently, with attention to detail and a passion for working with processes and procedures.
Job Description:
- Develop and maintain the PV Quality Management System in collaboration with subject matter authorities.
- Coordinate the assignment of adverse event (AE) & product complaint (PC) training globally to vendors.
- Create a training program for all individuals within the GPS and relevant personnel involved in GVP.
- Regularly review all procedures to ensure they accurately reflect the GPS activities being followed.
- Monitor compliance with required training and address non-compliance by working with line management.
- Lead or participate in initiatives to continuously improve the effectiveness and efficiency of GPS processes.
- Maintain the AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed to support contract review/update.
Requirements:
- 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
- Bachelor's degree required.
- Extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
- Consistent record of successful project management related to quality management.
