7 Biochemistry jobs in Onex found

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