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Job Overview
Employment Type
Full-time
Compensation
Hourly
Range $20.00 - $32.75
Work Schedule
Flexible
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
employee wellness program
Professional Development
Flexible work schedule
Job Description
CSL Behring is a global biotherapeutics leader driven by a commitment to save lives and improve patient outcomes worldwide. As part of CSL, which is headquartered in Melbourne, Australia, and employs over 32,000 people globally, CSL Behring focuses on discovering, developing, and delivering innovative therapies for people living with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Utilizing advanced scientific platforms such as plasma fractionation, recombinant protein technology, and cell and gene therapy, CSL Behring continuously refines its approach to meet unmet medical needs and help patients lead fuller lives. Moreover, CSL operates one of the... Show More
Job Requirements
- Bachelor's degree or equivalent in nursing, pharmacy, or related field
- Minimum 10 years of clinical trial and post-marketing pharmacovigilance experience
- At least 5 years of managerial or leadership experience
- Proficient knowledge of global pharmacovigilance databases and regulations
- Strong analytical and problem-solving skills
- Ability to manage cross-functional teams and projects
- Excellent communication skills
- Experience with electronic submission of safety reports
- Ability to work in a hybrid work environment
Job Qualifications
- Bachelor's degree or equivalent in Nursing, Pharmacy, or related field
- Minimum 10 years of clinical trial and post-marketing pharmacovigilance experience
- At least 5 years of managerial or leadership experience
- Proficient knowledge of global pharmacovigilance databases and regulatory rules
- Strong analytical skills to interpret complex regulatory intelligence
- Experience leading process improvement initiatives
- Excellent communication and stakeholder management skills
- Ability to work collaboratively in cross-functional teams
- Knowledge of electronic ICSR reporting standards
Job Duties
- Oversee intake and triage of all incoming safety data including spontaneous, literature, and partner reports
- Monitor outbound submissions to regulators, affiliates, and partners including E2B tracking and acknowledgments
- Coordinate follow-up activities ensuring timely and appropriate vendor queries and responses
- Provide oversight to ensure global reporting compliance with country-specific regulatory and business requirements related to expedited adverse event reporting
- Regularly analyze complex regulatory intelligence underpinning reporting requirements and collaborate with interface teams to implement changes
- Continuously monitor and support improvements on electronic submission of Individual Case Safety Reports (ICSRs) including daily monitoring of reporting and reportability in the safety database
- Analyze causes of missed reports and take corrective actions including liaising with vendors and training
- Review interventional clinical trial studies and study specific reporting rules collaborating with clinical and risk management teams
- Lead initiatives to develop or optimize processes related to expedited reporting and foster cross-business collaboration
- Serve as SME for inspections and audits related to database reporting and submission oversight
- Support database projects ensuring reporting requirements are met and influence enterprise-level solutions
Job Qualifications
Experience
Expert Level (7+ years)
Job Location
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