Associate Director, Global Patient Safety

Associate Director, Global Patient Safety

Job description

Regeneron is seeking an Associate Director in Global Patient Safety, this position is a pivotal role within Regeneron's Global Patient Safety organization, specifically in the Case Evaluation & Reporting area.

We need someone who will coordinate pharmacovigilance operations, ensuring efficient vendor and case processing to meet regulatory standards.

You will play a key role in inspection readiness, quality control of PV deliverables, and adherence to case submission timelines.

As an Associate Director in GPS, your typical day might include :

- Leading all aspects of case processing deliverables with accuracy.
- Contributing to the tactical planning for global staff development and capacity.






- Providing mentorship and support to your team members.
- Collaborating with auditors and health authority inspectors.
- Ensuring compliance with all regulations, guidelines, guidances and Regeneron SOPs and Working Instructions governing pharmacovigilance.
- Leading and supporting your direct and indirect reports.
- Manging workload and support staff in meeting compliance objectives, optimizing job performance / contributions, and achieving high levels of work quality.

This role might be for you if :

- A collaborative professional who builds positive relationships with cross-functional stakeholders.
- A process focused individual with a strong ability to adapt to situations.
- You are a resilient problem-solver and overcome challenges and find solutions.
- You are passionate about mentoring and developing talent, and can successfully navigate uncertainty by putting structure and process in place.
- You excel at finding novel solutions using available data.

To be considered for this opportunity, you must have a Bachelor,





or equivalent degree. Proven pharmacovigilance / drug safety experience in the pharmaceutical / biotech industry is essential, with at least 10 years of proven experience, including clinical and post-marketing expertise.

We require someone with a strong understanding of FDA, EU, and ICH guidelines governing pharmacovigilance. Additionally, we seek someone with expertise in leading and supervising teams on complex projects and a successful track record of collaboration across functional teams.

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.

▶️ Associate Director, Global Patient Safety
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