Safety Vigilance Specialist

Teoxane SA

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  • Publication date:

    19 February 2024
  • Workload:

    100%
  • Contract type:

    Unlimited employment
  • Language:

    English (Fluent), French (Fluent)
  • Place of work:

    Genf

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

Safety Vigilance 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 :

Safety Vigilance Specialist

Main activities

Customer complaint conformity activities :

  • Ensures the regulation changes are transmitted to the Safety Database for update and configurations
  • Participate in the implementation of a reconciliation process, as well as traceability feedback via mock complaint exercises for subsidiaries and distributors
  • In charge of Reportability Assessment Review and Quality Check of complaints upon request

Compliance of post-market processes in accordance with the Medical Device Regulation (2017/745) and other international applicable regulations :

  • Implement a vigilance watch including the appropriate use and maintenance of the Vigilance Database for Safety reporting
  • Review, twice a year, of any publications by National Competent Authorities regarding dermal fillers (NCA watch)
  • Leads on the Tarius-Vigilance Database related activities
  • Evaluating the gaps between Teoxane process and the relevant regulation in force
  • Participate in the review of distributor commitments in terms of safety (eg. Review of partners contracts, involvement in the periodic distributor evaluation)
  • Develop and update Safety procedures wherever needed, mainly the Safety Vigilance SOPs and plans
  • Participate whenever needed to audits and inspections including competent authorities audit representing the department
  • Any other special mission that may be entrusted by the department

Regulatory reporting :

  • Implementation of safety and regulatory reports as required
  • Participation in the gap analyses of transversal projects or new regulations, representing the safety department
  • Response ad-hoc to queries raised by the regulatory department pertaining to the safety of Teoxane products
  • Involvement in the PSUR for Teoxane products, as well as the impact analysis of new projects (new products, geo expansion-)
  • Support implementation of the products safety profiles

Your profile

  • Pharmacist Diploma, University, EPF, HES or Engineer Degree in Life Science
  • At least 3 years of experience in medical devices or medicinal drugs environment
  • Experience in safety vigilance activities and specifically in the use of a safety database
  • Ability to rapidly adapt to changing environment and circumstances
  • Fluency in English and French

Av. de Lyon 105 1203 Genève

Contact

  • Teoxane SA

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