Case Manager

Case Manager -

The Case Manager is responsible for all aspects of case processing in pharmacovigilance and fully responsible for the assessment and evaluation of non-serious case reports. Case Manager is responsible for processing single case data in the global pharmacovigilance database. This implies primary responsibility for accurately processing adverse event reports from all sources according to regulatory guidelines, company SOPs and Pharmacovigilance Agreements in the global pharmacovigilance database. Further he/she creates the narrative and proposes listedness assessment for serious cases reports while being fully responsible for the processing and evaluation of non-serious cases including causality assessment.

Responsibilities:

1. Single Case Processing

• Triage of incoming case reports

• Perform duplicate check in the global safety database to avoid duplicate reporting to Regulators

• Prompt and accurate case entry into global safety database

• Create and propose case narratives

• Perform coding of adverse events, indications, medical history/conditions using the regulatory required MedDRA terminology

• Recognize, extract, assess and code relevant laboratory data

• Perform coding of medicinal products using WHO Drug Dictionary

• Propose seriousness & listedness

• Recognize off label use (Global) and (US) for the reported indication

• Check data for consistency and completeness of data

• Perform unblinding step of blinded SUSAR during clinical trial following the confirmation from Medical Evaluation

• Perform End of Study Unblinding

2. Fully responsible for the assessment and evaluation of non-serious case reports

3. Oversight on single case workflow

• Propose pertinent follow-up for the completion of case reports from CSL Safety

• Officers, physicians, patients and other reporter types

• Tracking of follow-up activities

4. Archiving & Documentation

• Electronic archiving of single case report source documents within the Safety Database

• Archiving of paper reports if locally required (US and Australia only)

5. Generate reports from global safety database relevant for single case processing

6. Perform monthly reconciliation for assigned CSL sponsored clinical trials

7. Assist Case Management lead in writing SAE reporting plans

8. Monitoring of Global Case Management Inbox and initiate required activities

Required Qualifications:

• Minimum of a Bachelor's Degree required; Nurse, Physician Assistant, Medical Documentarian or related focus preferred

• Minimum of 3 years relevant work experience required;

• Good understanding of medical terminology

Preferred Qualifications:

• Nursing and/or pharmacovigilance experience preferred

• Global pharmacovigilance database knowledge is preferred along with proficient knowledge of regulatory roles and regulations, locally as well as globally.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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