PMS Specialist

PMS Specialist

My client is an innovating, dynamic and growing international medical device company currently expanding their team in Switzerland, Geneva canton. Due to this growth my client is looking for PMS Specialist to join there regulatory affairs’s team.

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
  • In connection to R&D and Clinical team, analyze, adapt and translate technical information related to the 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 Teoxane 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 in connection 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

YOUR PROFILE:

  • Master in regulatory affairs or equivalent with minimum 3/5 years experience in a similar position
  • Strong knowledge with medical devices 
  • Strong knowledge with QSM and risk management
  • Fluent in  English (speak and write)

For more details, please contact Marine Dollat at mdollat@axepta.com

Marine Dollat mdollat@axepta.com

Specialist Pharmaceutical and Medical Device recruiter and headhunter recruiting in Switzerland and France for the provision of Pharma and Medical Device staff including Quality (GCP, GMP, GLP, GxP, Quality System, Quality Engineer, Quality manager, Quality director and VP level), Regulatory Affairs or Production's position. As specialists in the placement of candidates within the Pharmaceutical Industry, our service is thorough, professional and intelligent. In addition to our permanent and contract recruitment services, we provide proactive search campaigns, advertising campaigns and dedicated account management. If you would like to have a confidential discussion regarding your search for staff or your search for a new position please feel free to contact me directly at mdollat@axepta.com