Associate Director PV

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Job details

Company overview

We are a global company in the pharmaceutical industry, engaged in research, development, manufacturing, and sales of pharmaceuticals. Our mission is to discover, develop, and provide innovative medicines to help patients with serious illnesses. As leaders in the future of the healthcare industry, we prioritize "Focus, Innovation, Compassion." We focus on disease areas with significant unmet medical needs and aim to guide people to new hope and contribute to improving their quality of life through the provision of innovative medicines and services.

Responsibilities

• 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

• 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.

Key Competency Requirements:

• 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