Regeneron Pharmaceuticals Jobs

You will be responsible for a variety of duties as Senior Manager Global Patient Safety.

A typical day may include:

• Authors new and updates to SOPs and Working Instructions and conduct related training.

• Standardize on PV/PMS process and workflow, and support to implement and maintenance the safety database.

• Build the annual GVP/GPSP training and education plan, lead the training record and build the annual report.

• Builds the annual GVP/GPSP self-inspection plan and the report to PV director. Performs the self-inspection if needed.

• Maintains and stores the GVP/GPSP crucial document based on the Japan regulation and global SOPs.

• Collaborates with the stakeholders sat the external/internal audit and the Regulatory Authority Inspection.

• Takes initiative in the ongoing process improvement for quality and compliance.

• Monitors that PV service vendor performance is appropriately, and they are following the contract and project management plan.

This may be for you if:

• Well informed on relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

• Proven success in working on cross-functional teams such as Regulatory Affairs, Sales and Marketing and clinical development.

• Contributes and leads organizational projects and goals to support their timely completion.

• Experience with supporting or leading regulatory authority inspection such as PMDA Re-examination, MAH license renews and GCP Reliability Inspection.

• Experience with leading complex projects, such as function/team improvement project, Safety Database implementation project, Business license succession including safety data transferring.

To be considered ,

• Bachelor’s Degree or equivalent experience, Pharmacist (preferable)

• GVP/GPSP self-inspection, SOP administrative work.

• Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required, over 5 years of Pharmacovigilance/Drug Safety experience.

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.