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Division

Research and Development / Worldwide Patient Safety / International Patient Safety/Patient Safety Japan

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary

This role provides strategic leadership in the effective management of the Rev Mate Pregnancy Prevention program (PPP) for IMiD products and the design and implementation of PPP risk minimization measures for any future assets, where required. As a member of the Patient Safety Japan (PSJ) Leadership Team, drives organization change and development of the team and represents PSJ across the organization through strong cross-functional partnerships.

Key activities:

• To ensure the benefit-risk balance across the product lifecycle remains favorable for the relevant products by executing appropriate safety measures in line with MHLW-agreed requirements.
• To ensure the structure, performance and effective oversight of the end-to-end operations of Rev Mate for post marketing IMiD products and future Pregnancy Prevention Programs (PPP) for additional assets in Japan are effective, robust and efficient.
• Leads a team of several members and manages vendors involved in the execution of the PPP.
• To contribute to R&D activities and drive implementation strategies to design and implement future PPPs for investigational assets that include this requirement.
• To communication and collaborate effectively with internal and external stakeholders to ensure effective management and governance of the PPPs and close collaboration to achieve the program’s intended objectives.
• To ensure excellent regulatory compliance and credibility with MHLW, PMDA, HCPs, patients and other associations.

Position Responsibilities

Risk minimization of IMiD/CELMoD products (PPP)

• Ensure the required revisions of Rev Mate at appropriate timings
• Ensures the activities of Rev Mate center to comply Rev Mate
• Ensures the implementation of required education to comply Rev Mate
• Supervises the required audits to comply Rev Mate
• Supervises the activities of on-site workers to comply Rev Mate
• Ensures the operation of Rev Mate steering committee to comply Rev Mate
• Ensures the effective communication with internal stakeholders like Soseli, Anseki, Brand team, Compliance, Legal and etc. Ensures the appropriate communications with eternal organizations associated with Rev Mate (the 3rd party evaluation committee, MHLW, etc)
• Ensures development of PPP documents for clinical studies

Cross-functional collaboration

• Supports the clinical study team from safety perspective
• Trains staff on product safety profile and risk minimization measures.
• Lead the cross-functional team in the event of changes, deviations or improvements being required for a PPP to assess impact, drive decision making and ensure effective implementation.
• Frequently interacts with global teams (including Global Risk Management, Safety Management Teams, WWPS IT) to drive implementation strategies and ensures full alignment and utilization of global resources and expertise.

Safety control activities/ compliance

• Ensures the awareness of the changes in regulations and evaluates the impact on local processes.
• Ensures the appropriate safety vigilance procedure and in interactions with other department and Global Drug Safety and Risk Management (GDSRM).

Degree Requirements

1. Unuversity degree

2. Fluent in Japanese and English with ability to work in global context

Experience Requirements

Required experience

• Ten (10) years pharmaceutical/biotechnology industry experience
• Five (5) years management experience
• Project management experience preferred

Required knowledge

• Global / local Pharmacovigilance/safety regulatory requirement (Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GVP, GPSP, etc.)
• Pharmaceutical and Science background preferred

Key Competency Requirements

• People management skill
• Group Leadership
• Negotiation/ cross-functional collaboration skill
• Presentation skills
• Resource and vendor management

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1596531 : Director, Reve Mate and PPP