The Associate Director shall report to GPS Director in Japan and performs as deputy Anseki (Safety Control Manager) and Choseki (Post-Marketing Surveillance Manager) as needed.
Responsibilities include the management and oversight of external service providers providing services related to GxPs operation, the establishment of the J-RMP, and who contribute to the J-NDA and annual report.
Job Duties
Serve as the primary backup for the Head of Japan PV including but not limited to acting as the Deputy Anseki when required and supporting the Choseki as needed.
Manage and oversee CRO performance related to all outsourced safety operations.
Establish and maintain J-RMP operations including the risk minimization plan.
Contribute to the safety sections of the J-NDA and support the resolution of any PMDA inquiries.
Takes initiative in ongoing process improvement related to quality and compliance.
Establish and maintain metrics for to ensure compliance and satisfactory performance for Safety relevant operations.
Support the development of periodic annual reports such as J-DSUR, J-PSUR, and annual infection report.
Job Requirements
Education
Bachelor's degree (advanced degree preferred)
Experience
More than 8 years' experience in Pharmacovigilance and PMS operations
Well informed on relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
Demonstrates the ability to collaborate with cross-functional teams such as Medical Affairs, Regulatory Affairs, Sales, Marketing and clinical development.Experience leading regulatory authority inspection such as PMDA Re-examination, MAH license renewal and GCP Reliability Inspection.
Experience managing complex projects, such as function/team improvement projects, Safety Database implementation projects, Business license succession including safety data migrations.
Experience supporting the J-RMP, JPI establishment and maintenance, and drafting Japan annual reports (i.e. J-DSUR, J-PSUR) and re-examination dossier.Over 8 years Pharmacovigilance/Drug Safety experience including case processing and PMS in the pharmaceutical / biotech industry required.
Experience with vendor selecting, managing external service providers which have been entrusted with GxPs operations (GCP/GVP/GPSP) on pharmaceutical products, regenerative products and medical devices.
Prior global pharmacovigilance experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive culture that provides comprehensive benefits, which vary by location.
In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site.Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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.
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.
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