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
-
- 必須
- Experience in Pharmacovigilance
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY14,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays
