Clinical Post Market Surveillance – Medical Devices

Clinical Post Market Surveillance – Medical Devices

Job Description

Responsiblities

  • 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
  • In connection to R&D and Clinical team,analyze, adapt and translate technical information related to products into medical information suitable for the marketing team
  • 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
  • Regulatory watch: PMS, clinical, MD vigilance,Medical Affairs
  • National health authorities website surveillance,including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence(performance and safety vs competitors)
  • Track competitors data performance (clinical studies) and safety (vigilance)
  • Ensure that post marketing procedures, processes and documentation meet the regulations in all subsidaries
  • 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 inconnection with medical affairs
  • Participation in the improvement of processes,procedures, instructions, forms, tools and database in relation to the activities of the Medical Affairs Department
  • Participation to Audits

Secondary activities:

  • Respect the safety rules and apply the instructions in force,
  • Report all situations of risk to her manager or co-workers,
  • Do not expose his colleagues in situations of danger,
  • Use the measures of protection of collective and individual required foractivity

 

KNOWLEDGES and SKILLS required:

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

  • Scientific training
  • Experience in the Medical Device industries
  • QSM and risk management skills
  • French and English, another language an asset
  • Good writing and communication skills
  • Control of Pack Office

Job Type: Full-time

Please send your application to Jean de La Fournière: jean@axepta.com

Jean De La Fourniere delafourniere@axepta.com