Pms Complaints Manager

Vor 2 Tagen


Geneve, Schweiz Axepta SA Vollzeit

We are looking for a **PMS Complaints Lead**, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices.

**Responsibilities**:
PMS Complaints management
- Oversee the Case Management activities including triage and reportability assessment
- Oversee Quality Review and Medical Case Assessment of the customer complaints
- Liaise with QA Management to lead the complaints investigations management
- Responsible for due diligence compliance for the compliance on reporting to the relevant competent authorities and notified body
- Oversee the interactions with the local KOLs for medical assistance or any other medical assessment request
- Developing and implementing KPIs related to complaints handling activities
- Leading reconciliation processes with affiliate, local partners and other stakeholders e.g. EU Importer
- Ensure appropriate use and maintenance of the Safety database in compliance with international regulatory authorities
- Review of PSUR or other annual reports as needed

Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations
- In charge of Training of the team for PMS Complaint handling activities for medical devices
- Review and approve Safety SOPs and plans
- Oversee CAPA and any findings related to the PMS Safety activities
- Participate to Audit and Inspections representing the department

Clinical Safety Reports management
- Support processing of the clinical safety reports (pregnancy, SAE/AESI, device malfunction) as needed
- Support due diligence compliance for reporting to the relevant competent authorities and Ethic Committees
- Involvement in the Clinical Protocol, IB or other study documents for the PMS related sections as needed
- Involvement in the review of clinical periodic (annual) reports for the specific safety sections as needed

**Profile**:

- Pharmacist or other relevant Life-Science Master discipline e.g. Biochemistry, Biological Sciences
- At least 5 years of experience in class III medical devices complaints management
- Experience in safety vigilance activities and specifically in the use of a safety database
- Previous experience with people management (minimum 1 year)
- Fluent in English and French



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