Post-Market Surveillance Specialist

PRIMARY ACTIVITIES :

PMS Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations: Ensure high quality standards

• Coordinate Post marketing Surveillance procedures, processes and documentation to meet the regulations in all Teoxane subsidiaries.
• Participate to CAPA and any findings related to the PMS Safety activities.
• Participate to Audit and Inspections representing the department."¯
• Participate to Change Board, CAPA Board, Risk Management Board, Quality Committee.
• Participation in the improvement of processes, procedures, instructions, forms, tools and databases in relation to the activities of the Safety Department.
• Participate to Field Safety Actions.

PMS Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations: Collect, trend and escalate data related to Post marketing Surveillance

• Participation in safety risk management processes, including updates of the preliminary hazard analysis (PHA) document, HRA Risk Reviews.
• Participate to PMS periodic documentation such as the PMS PLAN and the PSUR for Teoxane products, CER and PMCF.
• Participate to product surveillance data preparation for regulatory, Quality, Clinical, R&D, Medical Affairs and Marketing team.
• Participate to aggregate data preparation for PMA (incl. Annual Reports) and IDE preparation.
• Participate to preparation of periodic National Competent Authorities (NCA) watch focusing on the safety aspects of the publications by the main NCAs.
• Involved in the periodic review of KPIs to be presented through management reviews, vigilance committees, audits, inspections as well as incoming ad-hoc meetings.

Participate in the continuous improvement of the safety department and the good integration of safety-related activities within Teoxane

• Participate to vigilance system implementation locally.
• Participate to the mock complaint exercises for traceability of our partners, as well as to ensure the efficient customer feedback flow within partners.
• Participate to Audit and competent authorities' inspections representing the department.
• Participate in the partners' contracts for vigilance related activities as needed.
• Any other mission that could be given by the Management.

SECONDARY ACTIVITIES

• Be compliant with the safety regulations and apply the applicable instructions,
• Report all situations of risks to his manager or co-workers,
• Do not expose his colleagues to situations of danger,
• Use the measures of protection of collective and individual required for activity

PROFIL :

Minimum level of training and/or professional experience required by the position:

• Pharmacist or other relevant Life-Science Master discipline e.g. Biochemistry, Biological Sciences.
• At least 3 years of experience in class III medical devices PMS activities.
• Experience in safety vigilance activities and specifically in the use of a safety database.
• Ability to rapidly adapt to changing environment and circumstances.
• Previous experience with people management.
• Fluency in English and French.