Digital Risk Management Consultant
The Digital Risk Management (DRM) organization at Pfizer delivers risk management and compliance services to ensure Digital services and solutions meet general controls and regulatory requirements.
This role will collaborate with Digital partners to:
- Deliver risk management and compliance services to assigned Digital teams
- Participate in routine reporting to assigned Digital lines on the state of compliance
- Liaise with Risk Management managed service providers to ensure BTQA roles are being fulfilled for all assigned Digital projects
- Review and approve Solution Development Life Cycle (SDLC) deliverables or change management deliverables
- Support completion of Solution Profiles; confirm/approve Solution Profiles
- Assure compliance requirements are met and approve deviations, where applicable
- Assure audit/inspection awareness and preparedness
- Support audits and inspections of Digital
- Support the monitoring of Digital process execution to identify targeted continuous improvement efforts to improve operational process effectiveness and control execution
- Assist with defined compliance strategic projects/initiatives, and manage associated records and activity tracking
- Support multiple compliance-related projects and initiatives simultaneously
Key Responsibilities
- Japanese language skills with native equivalent level
- Deep understanding of Japan customs & culture with focus on interaction with local regulators and authorities
- Updated knowledge of Japanese regulations, i.e. jGxP (GCP, GPSP, GVP, GMP...), Personal Information Protection (Healthcare Information, etc.), AI related implications, etc.
- Fluent in Japanese, English, and Chinese
- 3+ years of experience in pharmaceutical or other regulated industry
- Excellent oral and written communications
- Ability to proactively solve complex problems both individually and as part of a team
- Ability to work independently and manage multiple priorities
Requirements
- Quick to establish trust and respect
- Action-oriented and energetic
- Resourceful and avid learner
- Easily make connections
- Effective oral, written, and interpersonal communications skills
- Organizational, planning, and administrative abilities
Physical/Mental Requirements
- Extensive computer use
Non-Standard Work Schedule, Travel or Environment Requirements
- Primary location within +/- 1 or 2 hours time difference from Japan
- Non-standard work schedule may be required
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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