Post-Market Surveillance Coordinator

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. 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 :

 

Post-Market Surveillance Coordinator (Vigilance / Complaints)

Main responsibilities

Complaints Management :

• In charge of case processing starting from receiving complaints, proceed with needed investigations and closure of the case
• When applicable, report to the relevant competent authorities and notified body
• When applicable, liaise with the local KOLs for medical assistance
• Ensure appropriate use and maintenance of the Teoxane safety database in compliance with international regulatory authorities

PMS Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations :

• In charge of Regulatory and normative watch specific to Post Marketing Surveillance, with particular attention medical device vigilance
• Update wherever needed of internal medical affairs SOPs and guidance
• Follow up of CAPA and any findings related to the medical affairs department
• Participate to the CAPA Board
• Participate to the risk management process as representative of the medical affairs department
• Participate whenever needed to Audit including competent authorities audit representing the department

Education and Qualifications

• Bachelor degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• At least 2 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