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Case Management Specialist
vor 2 Wochen
Main activities
- Provide scientific support to the case management coordinators for medical assessment of cases
- Lead case management team meetings and provide feedback on identified issues
- Conduct quality and medical reviews of cases in the safety database
- Act as safety referent for signal detection activities
- Ensure resources are available for employee onboarding in complaint management
- Participate in training new employees in complaint management
Manage complaints:
- Handle case processing from receipt of complaints to closure after necessary investigations
- Collaborate with local Key Opinion Leaders for medical support when required
- Ensure proper utilization of the Teoxane safety database in line with regulatory requirements
- Report to relevant competent authorities, notified bodies, and authorized representatives as needed
- Conduct reconciliations with local affiliates and partners
Maintain Safety Quality system conforming to Medical Device Regulation and other applicable regulations:
- Address non-conformities and audit findings in the safety department
- Participate in reviewing and updating internal safety SOPs and guidelines as necessary
- Contribute to audits, including those by competent authorities
Your profile
- Hold a Bachelor's degree in a relevant scientific field such as Biochemistry, Microbiology, Pharmacy, Biological Sciences, or Related Pharmaceutical Science
- Minimum 3 years of experience in medical devices or pharmaceuticals
- Experience in safety surveillance activities and use of safety databases
- Ability to adapt quickly to changing environments
- Proficiency in English and French
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