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Associate Director Training
il y a 4 semaines
We are seeking a highly skilled Associate Director to lead our Pharmacovigilance (PV) Quality Management System. As a key member of our team, you will be responsible for maintaining the PV Quality Management System in collaboration with subject matter authorities.
Key Responsibilities:- Develop and maintain the PV Quality Management System, ensuring compliance with regulatory requirements.
- Coordinate the assignment of adverse event (AE) & product complaint (PC) training globally to vendors.
- Create a comprehensive training program for all individuals within the GPS and relevant personnel involved in GVP.
- Monitor compliance with required training and address non-compliance by working with line management.
- Maintain the AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed to support contract review/update.
- Bachelor's degree in a relevant field.
- Previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
- Consistent record of successful project management related to quality management.
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.