We are looking for a Senior Drug Safety Manager with a strong background in GVP operational experience. This role will provide an opportunity to ensure our systems matter by updating procedures with our Japanese partners and working on local SOPs. We are a small yet multifaceted organisation on the path of consistent expansion, where each team member’s contribution is invaluable. Join us in building an environment where your insights can contribute to our direction and impact in the industry.

A typical day may include:

Developing new and updates to SOPs and Working Instructions and conduct related training.

Building PV/PMS processes, maintaining the safety database, and crafting the annual GVP/GPSP training plan.

Formulating the self-inspection plan and reports to the PV director,

Handling and storing the GVP/GPSP crucial document based on the Japan regulation and global SOPs.

Engaging with collaborators and the external/internal audit and the Regulatory Authority Inspection.

Leading all aspects of the PV service vendor performance and ensuring they are following the contract and project management plan.

This role might be for you if:

You are well-informed on PMDA/MHLW and ICH guidelines, initiatives, and regulations for pharmacovigilance in clinical trials and post-marketing.

You have shown success in working on cross-functional teams such as Regulatory Affairs, Sales and Marketing and clinical development.

You excel in leading organisational projects and goals to support their timely completion.

Experienced in leading regulatory inspections and complex projects, including team improvement and safety database implementation.

To be considered for this opportunity, we require a Bachelor’s degree or equivalent experience (Pharmacist preferred), at least 5 years of relevant pharmacovigilance experience in the pharmaceutical or biotech industry, and proven understanding of GVP/GPSP self-inspections and SOP administration. We are seeking a highly motivated and independent individual who can take initiative and effectively handle the safety database.

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.