Work Location , Expected Annual Income :
Tokyo,18.0M ～ 22.0M
About the Company :
Global European Pharmaceutical Manufacturer
Responsibilities :
Our Team:
The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable the company to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.
The PV Regions group is an international, dynamic, and culturally diverse team dedicated to the safety of our company's products in regions/countries.
The Country Safety Head ensures that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV Quality Documents (QDs) to warrant safe and appropriate use of our products in the assigned country.
Main Responsibilities:
- The face of the Safety organization in the country
- Accountable for all PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities.
- Ensures inspection readiness of the PV system in the country, serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)
- Builds & maintains all necessary relations/collaboration with the key PSPV stakeholders as well as other CSHs, and with the in-country partner functions (including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Leads).
- Accountable for local PV outsourced activities and PV compliance of local partnerships
- Accountable for local PV resources and budget with both local & global supporting functions
Benefits :
Employment Type: Full Time Employment
Work Location: Tokyo, Japan
Working Style: Hybrid work model with full flex time
People Management: Yes
Interview Steps: 4-5 with global stakeholder steps.
Budget: Up to 22mil annual base + bonus
Housing Support: Yes
Required Experience / Abilities / Skills :
Experience:
- Strong experience with PV systems & Regulatory Agency interactions
Soft Skills:
- Strong leadership
- Able to create networks and to collaborate in an international cross-functional environment.
- Self- motivated, ruthlessly prioritize to deliver most value.
- Solution oriented & strategic thinking while keeping patients and customers top of mind.
- Good communicator with attention to detail while seeing the big picture.
Technical Skills:
- Strong knowledge of pharmacovigilance systems & regulations
- Good understanding of how to manage safety data from multiple sources
- Able to evaluate & manage safety signals and define risk management activities
Education:
- Advanced health care discipline degree (MD preferred) or equivalent qualification