Enterprise Risk Consultant
4 days ago
The Digital Risk Management (DRM) organization at Pfizer is seeking a highly skilled and experienced Enterprise Risk Consultant to join our team. As an Enterprise Risk Consultant, you will play a critical role in ensuring that Digital services and solutions are planned, designed, deployed, operated, and supported in a manner that meets Digital general controls and regulatory requirements.
Key Responsibilities- Deliver risk management and compliance services to assigned Digital R&D teams, particularly in the Pfizer Digital Japan & APAC region.
- Participate in routine reporting to assigned Digital lines on the state of compliance.
- Liaise with the Risk Management managed service provider to ensure BTQA roles are being fulfilled for all assigned Digital projects.
- Review and approve Solution Development Life Cycle (SDLC - Waterfall/Agile methodology) deliverables or change management deliverables.
- Support completion of Solution Profiles; confirm and approve Solution Profiles.
- Assure compliance requirements are met and approve deviations, where applicable.
- Ensure audit/inspection awareness and preparedness.
- Support audits and inspections of Digital (prior, during, and post); work with Digital customers on the remediation of audit/inspection commitments and tracking of remediation status.
- 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 the associated records and activity tracking.
- Support multiple compliance-related projects and initiatives simultaneously.
- Bachelor's degree required; Information Security, Information Technology, Computer Science, Engineering, or related majors preferred.
- Native equivalent Japanese language skill, understanding at the level of local laws, regulations, and guidelines (reading, writing, speaking).
- Deep understanding of Japan customs and culture, with a 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 industries.
- Excellent oral and written communication skills.
- Able to proactively solve complex problems both individually and as part of a team.
- Ability to work independently and manage multiple priorities.
$80,000 - $120,000 per annum, depending on experience.
About PfizerPfizer 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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