BRS Consultant
Martin Tsvetkov
Pharma
Job number: Job-00223608
Posted: 2023-10-11
Associate Director PV
PV
12 - 16 million yen
Tokyo
Medical Device
Marketing
Job details
- Company overview
- Out client is a global company dealing with pharmaceutical products.
- Responsibilities
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- Responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
- Requirements
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- 5 years or more experience to interact with global counterpart(s) in a working environment.
- 5 years or more experience in general safety management division.
- 5 years or more experiences in supervising three or more member team, either as direct repots or multi-layer.
- 5 years or more experience in maintaining safety data management.
- Knowledge about Medical Information activities in Japanese industry including the role of Medical Representatives, expected contents and level among HCP.
- Basic knowledge about product-related data scheme including phases and composition of clinical development, characteristics of data from Japanese EPPV and PMS, Architecture of Common Technical Document etc.
- Knowledge about Pharmaceutical and Medical Device Act, Fair Competition Code (FCC), Promotion Code, and any other applicable regulations in Japan.
- Knowledge about Global PV Guideline (ICH-Ex).
- General skills of project management including schedule, budget, quality and issue.
- Communication skills as a professional in Japanese context as well as in global community, both internally and externally.
- Team management skills to lead a team, develop talents, nurture trust and confidence among members, and identify and address issues in a team.
- Evaluate the capability of the CRO under the objective systems, and maximize their ability.
- Advanced level of written English as non-native – can understand medical articles and general business documents in English without dictionary, can develop a document for any kind of job-related topics including complex ones.
- Advanced level as non-native speaker of oral English. Ability to discuss, negotiate and persuade in English within the responsible job-related topics, can represent organization's Pharmacovigilance Japan in a global meeting
- Salary
- 12 - 16 million yen
- Location
- Tokyo