Expert Post Market Surveillance

Expert Post Market Surveillance

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).

YOUR RESPONSIBILITIES:

  • 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

YOUR PROFILE:

  • 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 crahmouni@axepta.com

Chayma Rahmouni crahmouni@axepta.com