募集要項
- 募集背景
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<POSITION OVERVIEW>
The Post-Marketing Safety Controller's responsibilities include PMS, evaluation of safety information, planning and implementing countermeasures to ensure better safety and safety assurance training for other personnel. Responsible for ensuring proper documentation and filing of all product safety information including biologic reports as needed. These documents should be available as preparation for possible inquiry by PMDA.
The Post-Marketing Safety Controller will oversee all activities related to investigating complaint associated with product in Japan under the direction of department management. The Post-Marketing Safety Controller will perform complaint investigations and follow established global regulations for complaint handling.
- 仕事内容
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Anseki<RESPONSIBILITIES>
MANAGEMENT OF COMPLAINT SYSTEM
* Responsible for Good Vigilance Practice (GVP)
* Manage complaint database and files for all customer complaints in Japan.
* Assist with development and standardization of complaint investigations.
* Ensures procedures are in compliance with appropriate regulatory requirements.
COMPLAINT INVESTIGATION/REPORTABILITY OF ADVERSE EVENTS
* Perform reportability assessments
* Conducts clinical follow ups with customers in Japan as needed.
* Provide reports to health authorities on adverse incident and recalls.
* Maintains log of reportable events
* Overseas all aspect of the complaint investigation from opening to closure
* Reviewing complaint records for accuracy and completeness.
* Monitor safety of products released into the market
PROCESS DEVELOPMENT
* Responsible for process development to ensure compliance with PMDA regulations.
* Develops processes to ensure compliance with SOPs
BIOLOGICAL PRODUCT TRACKING PROCESS
* Enters daily shipping records and delivery records received from distributors into the traceability system
OTHER
* Trains employees in Japan on complaint and adverse event reporting.
* Provide ancillary support in representing the complaint handling process during audits
* Collecting data for post market studies as needed (Travel 5-10%) All other duties and tasks as required and requested by management.
Real is part of the larger SThree K.K group
To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com
Award winner of:
Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
- 応募資格
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- 必須
- Anseki
- フィットする人物像
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<QUALIFICATIONS>
* Bilingual; English and Japanese
* Knowledge of Ordinance #169, ISO 13485 and Japanese PMD Act
* Excellent written skills required due to frequent interaction with practicing ophthalmologists
* Prior experience with complaints management system
* Ability to manage reporting timelines and to train employees on complaint and investigation requirements
* Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
* At least three years in a post-marketing safety or quality assurance position at a pharmaceutical or medical device company
* Ophthalmology experience preferable.
* Bachelor's degree (preferably life sciences) at a minimum
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY10,000,000.00 - JPY12,000,000.00 per annum + competitive
