pms manager - class ii & iii - european medical device company.

Role Outline:The PMS Specialist (Manager) plays a crucial role in supporting the MAH supervisor by ensuring compliance with the Good Vigilance Practice (GVP) ordinance as a safety control supervisor under the PMDAct. This involves maintaining necessary business licenses for importation and distribution. Specifically, the specialist is tasked with maintaining a complaint reporting system that satisfies both GVP requirements and the company's Certification Procedure PQ2030, thus ensuring effective oversight of safety concerns and regulatory compliance.Tasks and ResponsibilitiesFeedback Management:-Obtain documented feedback on risk related to patients and operators using company products.-Utilize standard procedures for complaint reporting and regulatory reporting if necessary.-Maintain records of complaint closure.Manufacturer Communication:-Coordinate with the manufacturer to address complaints, including report submission, material shipment, investigation, and customer communication.-Liaise with customers through complainants to update them on complaint status, requests for information, and closure reports, potentially translating documents into Japanese.Post-Marketing Safety Information Collection:-Gather safety information beyond customer complaints from various sources such as health authorities, journals, congresses, and internet mailing lists.-Utilize the corporate vigilance network to assess risks from information outside Japan.-Present critical cases to the Quality Board for decision-making and potential reporting to regulatory authorities like PMDA.Regulatory Interface:-Serve as the interface with regulatory authorities (MHLW, PMDA, and local governments), supporting the Marketing Authorization Holder (MAH) supervisor.-Ensure regulatory requirements for communication between customers and the factory regarding complaints and corrective actions are met, adhering to company standard procedures even for non-company products.

求められる経験
Skills/Experience Required:

Education Requirements:
University degree or equivalent knowledge.

Preferred Education:

-Degrees in engineering, medical, or biological faculties.

Related Experience Requirements:

-Minimum of 3 years of experience in post-marketing safety (PMS) tasks in the medical device industry.

Preferred Experience:

-Experience in three key roles (General Manufacturing and Marketing Supervisor, Quality Assurance Manager, and Safety Control Manager) in the medical device industry.

Skills, Special Competencies, or Certifications Requirements:

-Business English proficiency for international communication.
-Up-to-date knowledge of regulations and standards both domestically and internationally.
-Current understanding of quality management systems and quality assurance.
-Familiarity with medical devices and their typical usage areas.
-Proficiency in basic PC software applications (MS Office).
-Strong communication, logical thinking, problem-solving, and self-management skills.
-Positive attitude, cooperation, teamwork, and flexibility.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収700 ～ 1,000万円

賞与
支給あり
雇用期間
期間の定めなし