Senior Manager, Global Patient Safety (Japan)

About the role

Regeneron, a biopharmaceutical company developing medicines for serious diseases, is looking for a Senior Manager, Global Patient Safety to join its Japan business. The role covers Japan pharmacovigilance reporting and compliance, works in a hybrid mode, and involves collaboration with cross-functional teams, external partners and service providers.

Key responsibilities

• Serve as the primary contact for Japan ICSR, research report and FSMT activities
• Review vendor-prepared safety evaluations and PMDA submissions for accuracy
• Oversee pharmacovigilance service providers and monitor contract compliance
• Drive process improvements that strengthen quality and compliance
• Author and update working instructions and deliver related training
• Contribute to J-RMP development and execution
• Partner with external departments and license partners on safety deliverables

Required profile

• More than 7 years of pharmacovigilance and post-marketing surveillance operations experience
• Prior global pharmacovigilance experience
• Experience supporting Japan aggregate reporting and local pharmacovigilance activities
• Experience managing external service providers and vendor relationships
• Experience supporting J-NDA safety content and responding to PMDA inquiries
• Experience with regulatory inspections, including PMDA re-examination, MAH license renewal or GCP reliability inspection
• Experience leading complex projects such as team improvement, safety database implementation or safety data migration
• Experience collaborating with Medical Affairs, Regulatory Affairs, Sales and Marketing and Clinical Development teams

Required skills

• Strong knowledge of PMDA, MHLW and ICH guidelines and regulations
• Project management and cross-functional collaboration skills

What we offer

• Total rewards package that may include annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits
• Reasonable accommodation during recruitment for applicants with known disabilities or chronic illnesses