Sr. Manager, ICSR Quality

Senior Manager, ICSR Quality

Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, you will be responsible for ensuring optimal quality of Individual Case Safety Reports (ICSRs) in the Global Safety Database. You will perform end-of-line Quality Assurance (QA) checks of IC SRs to ensure quality standards are maintained across CSL integrated and harmonized business units. This includes the quality of case processing vendors, generation of case quality metrics and trend analysis, and audit and inspection readiness and support.

You will bring your expertise in case processing standards across all products, case types and processes globally, as this is required. In addition, you will provide Safety Database Train the Trainer sessions for case processing vendor at onset of services and end user training internally for CSL.

This is a hybrid role, which offers a combination of an onsite and remote work schedule.

• Perform end of line quality check of IC SRs for correctness and completeness in comparison to source documentation and to ensure conformance with CSL Standards.
• Document findings and classify by root cause for errors.
• Send requests for corrections to the applicable Case Intake Mailbox in case of incorrect entries.
• Maintain expertise in case processing across all products, case types and processes globally.

• Generate monthly QA metrics and trend analysis across all case processing globally, inclusive of case processing vendor.
• Provide monthly feedback of findings to all Case Management including vendor.

• Prepare and maintain Global SDB training concepts and materials, inclusive of system overview, case management role‑based training, and observer training.
• Provide Global SDB training to CSL global case management roles and observer roles.
• Certify case management trainee for independence in case processing oversight by role.
• Perform “Train the Trainer” training for vendor and designated trainers as required.

Participation in global projects such as automation initiatives, integrations, process optimizations and system updates to reflect changes in regulatory requirements or to meet business requirements. Scope of responsibility includes quality review of documents, ensuring training requirements and materials are created to a high standard, and validation support as needed. Liaison with external departments to ensure successful outcomes through collaboration and clear communication.

This includes liaising with IT to resolve issues with the QA system and use of Power BI. Generate process‑relevant documents (SOP, work instructions). Audit/inspection readiness and support.

• University degree, medical documentarian, Master’s, PhD or equivalent in a life sciences discipline.
• More than 5 years of experience in pharmacovigilance, including Clinical Trials.
• Global pharmacovigilance database knowledge is required along with proficient knowledge of regulatory roles and regulations, locally as well as globally.
• Expert knowledge of drug safety processes, pronounced expertise in Single Case Management, in terms of database, clinical trials, and case entry.
• Experience with relevant software applications.
• Knowledge of CSL’s product portfolio and strong understanding of medical terminology.
• Strong sense of responsibility and accountability and special sense for diligence even for routine processes, proactive behavior and being able to keep timelines.
• Strong knowledge of GVP and ICH principles of SAE/AE reporting along with expert understanding of local and global regulatory roles and regulations.
• Ability to develop cooperative working relationships.
• Excellent Verbal and written communication skills in English language.
• Strong Knowledge in Good Documentation Practices & Good Pharmacovigilance Practices.
• Excellent Interpersonal skills.

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