Sr. Manager, ICSR Quality

The Opportunity:

Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, 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) check of ICSRs 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.  #LI-hybrid

The Role:

Quality Assurance (QA) of Individual Case Safety Reports (ICSRs):

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

Case Quality Metrics and Trend Analysis:

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

Case Management On-boarding and Global Safety Database (SDB) Training:

• Preparation and maintenance of 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.
• Certification of case management trainee for independence in case processing oversight by role.
• Performance Provide “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.
Generation of process-relevant documents (SOP, work instructions)
Audit/inspection readiness and support

Your Skills & Abilities:

• 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientif