Pharmacovigilance (PV) manager (Deputy of An-seki)

Job description

3266456
Additional Cities

Shinjuku-ku
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Life Sciences
Function

Quality
Country/Territory

Japan
Postal Code

169-0073
Role Summary/Purpose

PV manager (deputy of An-seki) supports An-seki and the PV function. This role is responsible for contributing to establishing and maintaining a local PV organization in Japan. This includes safety reporting processes using Argus J and local vendor(s) in accordance with global and local requirements. This role reports to SMS (Safety Management Supervisor, An-seki in Japanese).
Essential Responsibilities

PV manager is the essential roles to make pharmaceutical organization and market pharmaceutical products stable.
1. Manages activities in Japan consistent with applicable corporate GEHC policies and procedures as well as local regulations and practices (e.g. GVP, GPSP, GCP)
2. Accountable for expedited reporting of ICSRs, periodic reporting, risk management plan development and safety part labeling changes
3. Accountable for creating and maintaining SOPs and work instructions related to post-marketing activities
4. Together with An-seki, ensures there is a properly functioning PV system which includes establishing and maintaining a system which allows detection, collection, processing and reporting of adverse events, local literature monitoring, and maintaining a training system for PV related tasks.
5. Supports Global PV Case Processing team and PV Systems team in PV system upgrades and enhancements. Serves as SME in Japan PV systems requirements.
6. Manages local vendor(s) performing PV activities
7. Aligns local PV activities with global strategy by collaborating with relevant GEHC Life Sciences stakeholders
8. Supports inspection readiness activities and other inspection / audit-related activities
9. Work cross functionally with members of PV, MA, RA and provide proactive PV advice and support
10. Monitors new PV requirements and proactively provide stakeholders with PV guidance
11. Together with An-seki, build effective communications and processes with regulatory agency, industry associations, and business partners
Qualifications/Requirements

1. Minimum 3 years’ experience in pharmacovigilance at pharmaceutical industry.
2. Ability to communicate effectively in Japanese and English (both written and verbal).
3. Skills in working in a matrix-organization and communicating cross-functionally and cross-regionally
Desired Characteristics

1. PV supervisor (An-seki in Japanese) experience preferred
2. Safety database implementation experience preferred
3. Local vendor(s) selection/management skill/experience preferred
4. J-GVP SOP issue/maintenance experience preferred
5. Agency inspection experience preferred
6. Demonstrated ability to influence all levels of stakeholders at a multi-national organization
7. Demonstrated knowledge and experience to manage safety information collection and safety reporting to regulatory agency
8. Demonstrated ability to form, lead and manage cross-functional and cross-regional teams
9. Demonstrated problem-solving ability
10. Potential for 10-20% travel
About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
Primary Country

Japan
Primary State/Province

Tokyo
Primary City

Shinjuku-ku