Main activities
Complaints Management team cross functional support:
- Scientific support for the case management coordinators (medical assessment of the cases)
- Lead the case management team meetings and give feedback on detected issues with case management activities
- Perform the quality review and the medical review of the cases in the safety database
- Safety referent for signal detection activities
- Provide necessary resources to ensure all employees onboarding on complaint management
- Participate to new commers training on complaint management
Complaints Management:
- Case processing starting from receiving complaints, proceed with needed investigations, data entry and closure of the cases
- When applicable, liaise with the local KOLs for medical assistance
- Ensure appropriate use of the Teoxane safety database in compliance with international regulatory authorities
- When applicable, report to the relevant competent authorities, notified body and authorized representatives
- Perform reconciliation with local affiliates and local partners
Safety Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations:
- Follow up of non-conformities and any audit findings related to the safety department
- Wherever needed participate to review and update internal safety SOPs and guidance
- Participate whenever needed to Audit including competent authorities' audits
Your profile
- Bachelor's degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical 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