My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneva aera.
Due to this growth my client is looking for a PMS Specialist (new position).
- Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.
- Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
- Participate in the development of cross-functional document planning and review meetings
- Collect, trend and escalate data related to Post marketing Surveillance
- Develop PMS plans, PMCF plans, PSURs, and PMCF reports
- Participate to the development of the CER
- National health authorities website surveillance, including FSA (Field Safety Action)
- In charge of the Scientific literature intelligence (performance and safety vs competitors)
- Ensure that post marketing procedures, processes and documentation meet the regulations
- Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
- Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
- Participation on various committees (Change Board, CAPA Board, Risk Board, Quality Committee)
- Follow-up to the NCF, changes and CAPA in connection with medical affairs
- Bachelor or Master with minimum 6 years in a similar position
- Experience in the Medical Device industries
- QSM and risk management skills
- French and English, another language an asset
- Good writing and communication skills
Please feel free to contact me at email@example.com