募集要項
- 募集背景
- A world's leading biopharmaceutical company is looking for a PV Manager. The selected candidate will be responsible for ensuring regulatory compliance, managing CROs and vendors, executing safety processes, and supporting post-marketing vigilance.
- 仕事内容
-
A world's leading biopharmaceutical company is looking for a PV Manager.Responsibilities:
* Ensure regulatory compliance and credibility
* Manage and support vendors and CROs
* Execute safety processes and risk management
* Submit drugs and products on schedule
* Prepare and submit periodic safety reports
* Support post-marketing vigilance
* Contribute to safety question responses
* Interface with regulatory authorities
* Conduct training and self-inspections
* Prepare submission and marketing approval
* Prepare for regulatory inspections and audits
Requirements:
* Bachelor's degree or equivalent
* More than 5 years of pharmaceutical or biotechnology industry (including CROs) PV relevant experience
* Prior experience in sponsored clinical trial domestic case management
* Knowledge of PV requirements in Japan
* Proven experience in rare diseases is preferred
* Understanding of PMS is preferred
- 応募資格
-
- 必須
- More than 5 years of pharmaceutical or biotechnology industry (including CROs) PV relevant experience
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY15,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays
