We are seeking an Associate Director in GPS Standards & Training to maintain the Pharmacovigilance (PV) Quality Management System. This role is important for ensuring compliance with regulatory PV requirements in all relevant territories worldwide and operating efficiently and effectively in alignment with established industry practices.
As an Associate Director in GPS Standards & Training, your typical day might include:
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Developing and maintaining the PV Quality Management System in collaboration with subject matter authorities.
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Coordinating the assignment of adverse event (AE) & product complaint (PC) training globally to vendors.
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Creating a training program for all individuals within the GPS and relevant personnel involved in GVP.
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Regularly reviewing all procedures to ensure they accurately reflect the GPS activities being followed.
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Monitoring compliance with required training and addressing non-compliance by working with line management.
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Leading or participating in initiatives to continuously improve the effectiveness and efficiency of GPS processes.
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Maintaining the AE-PC contract language and liaising with Legal, Procurement, and Commercial as needed to support contract review/update.
This role might be for you if:
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You are a self-motivated individual who can drive projects independently.
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Attention to detail is your strength, and you enjoy working with processes and procedures.
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You are an influential person who can effectively communicate your ideas.
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You are resourceful and adaptable, able to manage your schedule and prioritize tasks.
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You possess excellent written and verbal communication skills.
To be considered for this opportunity, you must have at least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry. A Bachelor's degree is required. The ideal candidate must have previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems. Additionally, a consistent record of successful project management related to quality management is essential.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
