【英語を活かす】PVマネージャー/ PV Manager Global medical devices companyの転職・求人情報 31727109

募集要項

募集背景: A global medical devices company is seeking a Manager of Pharmacovigilance. The chosen candidate will ensure regulatory compliance, manage local safety oversight, and lead risk management activities.

仕事内容: A global medical devices company is seeking a Manager of Pharmacovigilance.
Responsibilities:

* Oversee pharmacovigilance activities according to local legislation
* Identify regulatory requirements for RMP submissions and implement local risk measures
* Conduct surveillance for safety issues and escalate concerns per protocols
* Maintain alignment with pharmacovigilance quality systems and company policies
* Prepare for audits, inspections, and manage CAPA activities
* Coordinate local case processing and ensure compliance with regulatory reporting requirements

Requirements:

* Experience in Pharmacovigilance
* Prior experience in managing a small to medium-sized team
* Understanding of Pharmacovigilance relevant local regulations
* Familiarity with international relevant regulations and standards (GVP and Green Book).
* Knowledge of MAH (Marketing Authorization Holder) license transfer, re-examination procedure, GVP inspection by Tokyo metropolitan government, and PV safety database maintenance, etc.
* Possess valid doctor or pharmacist licence is ideal
* Proficient in written and verbal English; proficient in written Japanese

応募資格

事業内容・会社の特長: An international manufacturer of medical supplies and equipment serving a wide range of hospitals, clinics, and other medical institutions. Leveraging its long history of quality and innovation, the company occupies a leading spot on the global stage.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

2121720/001