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Associate Director of Pharmacovigilance

Publication date 2025/10/29

Tokyo,15.0M ~ 20.0M

POSITION SUMMARY
This position leads the pharmacovigilance (PV) function in Japan, ensuring the effective delivery of PV consulting services to pharmaceutical companies. The role requires a balance of hands-on project delivery, team leadership, and business development responsibilities. The individual will build and develop a local PV team while collaborating closely with global colleagues to align with the overall practice strategy.

The role covers a broad scope of client engagements, from early development consulting to post-marketing PV strategies. It involves frequent client interaction, internal coordination, and participation in external networking and industry discussions.

RESPONSIBILITIES
Delivery
● Accountable for successful delivery of all PV consulting projects in Japan.
● Serve as a project leader or subject matter expert (SME) in PV where necessary.
● Provide guidance and problem-solving support to Japan-based consultants facing project challenges.
● Collaborate with the global team on staffing for Japan-based PV projects.

Business Development
● Identify and pursue new business opportunities based on client needs and market trends.
● Foster strong client relationships through regular communication and visits.
● Support proposal development and represent the Japan PV function at client meetings and industry events.

Team Development
● Collaborate with global and local leadership to define hiring needs and recruit local talent, including independent consultants.
● Lead onboarding, coaching, and performance management of PV team members in Japan.
● Serve as the go-to person and leader for the Japan PV team, ensuring team cohesion and alignment with company goals.

Thought Leadership
● Contribute to the strategic direction of the global PV practice, identifying opportunities for service expansion and innovation.
● Represent the company at industry forums, conferences, and networking events, sharing insights and thought leadership.

Medical Affairs Manager, Respiratory Device

Publication date 2025/10/29

Tokyo,10.0M ~ 12.0M

Roles and responsibilities
?Develop and execute academic strategies to establish standard of care in post-TL and post-tracheostomy rehabilitation

?Formulate medical communication plans based primarily on clinical data and evidence provided globally, and train relevant internal departments (primarily Sales, Clinical Support, and Marketing)

?Plan, utilize, and execute medical events for healthcare professionals domestically and internationally

?Roll out and run advisory boards within laryngectomy arena to drive consensus for post-TL rehab

?Evaluate and support domestic clinical research that can complement evidence generation initiatives driven by global MedSci

?Act as a counterpart to global MedSci (have a dotted report)

?Establish partnerships with KOLs and facilitate advisory boards to drive clinical excellence

Country Quality Management Manager, GxP

Publication date 2025/10/29

Tokyo,9.0M ~ 14.0M

Responsibilities:
製品の承認内容、GxPその他適用される規制、及び、当社の要件に対し日本としてのコンプライアンスを確保する。

上記に基づき品質システムを適切に実装し、実施・運用する。

適用される規制及び当社の要件に基づいて、製品の品質クレーム情報を管理する。

Global QD使用、Globalデータベースへの入力やデータベースからの情報取得、海外とのコミュニケーションが必須のため、これらが可能な英語のスキルが求められる。