Post Market Surveillance Specialist
TEOXANE SA - GENEVE
14.08.2019 | Employee | 100%

 

Teoxane Laboratories were founded in 2003 in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide.  Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

 

Post Market Surveillance Specialist

 

Main 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 TEOXANE 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 subsidiaries

 

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

 

14.08.2019
Employee, 100%

Required minimum profile

  • 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

Contact

TEOXANE SA
Rue de Lyon, 105
1203 GENEVE
TEOXANE SA
Rue de Lyon, 105
GENEVE

Industry

Biotechnology / Chemistry / Pharmaceutical

Year of foundation

2003
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