Work Location , Expected Annual Income :
Tokyo,10.0M ～ 13.0M
About the Company :
Global American Pharmaceutical Company
Responsibilities :
PV Roles & Responsibilities
- Deliver all PV activities per local regulations and IPSEN global/local SOPs
- Act as the local PV contact for GPS.
- Ensure accurate and timely reporting/follow-up of AEs and special situations with translation and QC in place.
- Conduct literature review to collect AEs and identify safety signals, escalate local signals or authority alerts.
- Compile monthly metrics, perform weekly/monthly reconciliations for AEs and PQCs (internal and vendors).
- Provide PV oversight to Risk Management Plans, ensure ARMMs are managed per requirements.
- Provide PV expertise across the business, maintain a comprehensive local PV system.
- Partner with Quality for compliant handling of product complaints and AEs.
- Prepare/review aggregate and ad hoc PV reports within regulatory timelines as requested (under GPS/country leadership).
- Support Patient Support Programs and PDCS (training, eligibility, documentation, Global Inventory updates).
- Monitor local regulatory requirements and inform QPPV Office and/or GRA of changes.
- Participate in affiliate/GPS meetings, escalate safety/compliance/operational issues to GPS and local leadership.
- Set and review local reporting rules in the global safety database.
- Deliver all PV activities per PMD-Act and JGVP Ordinance and our policies/SOPs, prepare/revise GVP-SOP.
- Ensure comprehensive JGVP system, complete documentation and provide JGVP training.
PMS Roles & Responsibilities
- Prepare PMS system setup with Safety Manager, GPS and related functions to enable launch readiness without hindrance.
- Deliver all PMS activities per PMD-Act and GPSP Ordinance and our policies/SOPs, prepare/revise GPSP-SOP.
- Prepare/submit PMS plans, implementation and results reports to regulatory authorities; prepare J-PSUR.
- Act as PMS contact to prepare protocol synopsis with ERGB stakeholders.
- Track monthly PMS progress and coordinate weekly/monthly with internal teams and vendors.
- Contribute to J-RMP with Safety Manager (GVP, GPSP) and plan/execute PMS as PVP of RMP.
- Prepare re-examination application materials and reporting to authorities with Safety Manager.
- Ensure comprehensive GPSP system, complete documentation and provide GPSP training.
Cross Functional / Oversight Role
- Liaise with distributors/partners and internal functions (Medical Affairs, Medical Information, Regulatory Affairs, etc.) to maintain oversight of workflows.
- Demonstrate scientific and business expertise relevant to therapeutic areas and competitive landscape.
- Support MI teams to forward safety reports to GPS Case Processing Centre, maintain knowledge of MI systems.
- Act as PV contact for local clinical trials; ensure timely safety collection/handling and reporting.
- Provide outcome reports to GPS and local management; oversee PV agreements and safety exchanges with partners.
- Collaborate with GRA on regional appendices/aggregate reports; coordinate with Global/Local MA on ongoing studies.
- Provide information to support PSMF maintenance.
Training, Audit, Inspection and CAPA Management
- Ensure regular audits of the local PV system, document outcomes.
- Coordinate deviations and CAPAs, track and implement corrective/preventive actions.
- Review local SOPs/Instructions for compliance with GVP, global SOPs, and local needs.
- Ensure timely archiving per SOPs and regulations.
- Develop/update training programs; maintain up-to-date training records.
- Prepare for inspections and internal audits; participate and support responses to findings.
- Ensure a tested business continuity plan with GPS and country leadership.
Benefits :
Employment Type: Full time employee
Office Location: Tokyo, Japan
Working Model: Hybrid
Interviews: 3
Budget: Up to 13 Mil (base+bonus)
Welfare and Insurances: Covered
Required Experience / Abilities / Skills :
Education / Certifications (Essential)
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field.
Education / Certifications (Preferred)
Advanced degree (PharmD, PhD, MD) is an advantage.
Knowledge & Experience (Essential)
3- 5 years in medical information and pharmacovigilance within pharma or related field.
Knowledge of regulatory standards (GVP, GPSP).
Knowledge & Experience (Preferred)
Understanding of clinical trials and marketing authorization processes.
Hands-on PMS experience.
Experience with J-RMP development and/or re-examination submissions.
Languages (Essential)
Japanese: Fluent
English: Business level