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Safety Compliance Specialist

évaluer
Avis soumis
14/03/2024 100% Contrat fixe
Travailler chez Teoxane SA
Teoxane SA

Vous retrouverez l'intégralité de nos offres d'emploi en cliquant ici : https://www.teoxane.com/.

Safety Compliance Specialist

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a :

Safey Compliance Specialist

Main activities

Ensure high quality standards for PMS and vigilance processes :

  • Oversight Post Marketing procedures, processes and documentation of Teoxane subsidiaries to ensure consistency with Global ones and compliance with regulations
  • Manage CAPAs, NCF and Change controls opened by the safety department and evaluate the impact of other CAPAs, NCFs and Change controls related to the safety of Teoxane products
  • Participate to NCF board, Change Board, CAPA Board, Quality Committee
  • Participate in the improvement of processes, procedures, instructions, forms, tools and databases in relation to the activities of the Safety Department
  • Prepare Health Risk Assessments of identified issues and involvement in the management of Field Safety Actions

Ensure the maintenance of quality standards for PMS plans and aggregate reports, as well as data management :

  • Participate to the redaction and/or review of PMS periodic documentation such as the PMS Plan, PSUR, CER and PMCF reports
  • Provide PMS data for Regulatory Affairs, Quality, Clinical, R&D, Medical Affairs and Marketing teams
  • Provide safety data for aggregate data preparation for IFU and SSCP/SSED preparation, including annual reports
  • Involved in the periodic review of KPIs to be presented through management reviews, vigilance committees, audits, inspections as well as incoming ad-hoc meetings

Responsible for the safety department risk management activities :

  • Participate in the safety risk management processes, including the surveillance process risk management
  • Manage the updates of the preliminary hazard analysis (PHA) document
  • Responsible for the upcoming Risk Management Data Reviews in regards to safety activities

Participate in the continuous improvement of the safety department and the good integration of safety-related activities within Teoxane and its subsidiaries :

  • Participate to vigilance system implementation locally
  • Responsible for to the mock complaint exercises for traceability of our partners, as well as to ensure the efficient customer feedback flow within partners
  • Participate to Audit and competent authorities' inspections representing the department
  • Responsible for the vigilance requirements assessment of partners' contracts as needed
  • Any other mission that could be given by the Management

Your profile

  • Pharmacist or other relevant Life-Science Master discipline e.g. Biochemistry, Biological Sciences
  • At least 3 years of experience in safety/vigilance activities, preferably in Class III medical devices PMS activities
  • Experience in the use of a safety database
  • Ability to rapidly adapt to changing environment and circumstances
  • Fluency in English and French

Contact

Service Recrutement

+41 (0)22 344 96 36

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À propos de l'entreprise