Job Description
Director, Medical Evaluation & Case Processing Oversight
Company: CSL
About the Role
You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs.
Key Responsibilities
Company: CSL
About the Role
You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs.
Key Responsibilities
- Oversight of Case Management Processes activities
- Oversight of Medical Evaluator role which completes medical review of the following ICSRs: All serious cases from all sources, Non-serious cases from company-sponsored clinical study, if required, Legal ICSRs (serious and non-serious), Reportable cases of combination products with ...
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