※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] PV Scientist
[Salary] 6〜10 million JPY ※Experiences and skills will be considered
The purpose of this role is to support the GPS safety strategy leads in order to provide integrated medical safety strategies for the assigned investigational and marketed products. This includes input into safety aspects of clinical development, risk management and benefit-risk management for assigned products.
Key responsibilities of the Pharmacovigilance Scientist within Safety Science include (but not limited to):
- Preparing dossiers submitted to Japanese Health Authorities
- Clinical trial activities
- Signal detection and management
- Benefit/Risk Activities
- (d)RMP (updates) and periodic safety reports
- Safety input into regulatory filings and associated submission activities
- Inspection/Audit Management
- Other activities
- MD: Clinical experience (preferably ≥ 2 years); PhD/advanced science degree: pharmaceutical industry experience (preferably ≥ 5 years) in an affiliate setting preferably in R&D organization or similar (e.g. Health Authority)
- Advanced experience in Pharmacovigilance (both in the clinical development as well as the post-marketing area)
- Advanced understanding of internal medicine, general medicine, epidemiology, pharmacology, Oncology/ Haematology
- Experienced in working in cross-functional, global teams, across different regions.
- Advanced understanding of the end to end drug lifecycle and basic knowledge of the drug development process
- Advanced knowledge of relevant regulation
- Advanced knowledge of interpreting individual cases and aggregate safety data
- Advanced understanding of the current approaches to benefit risk and signal management
- Demonstrated ability to author scientific reports
- Fluent in written and spoken English
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance