At a Glance
- Tasks: Lead medical evaluations and ensure high-quality safety assessments in a global team.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborative environment with opportunities to innovate and drive improvements.
- Why this job: Shape global medical strategies and improve patient safety with your expertise.
- Qualifications: Advanced medical degree and extensive experience in medical evaluation required.
The predicted salary is between 49500 - 60500 $ per year.
Join CSL as a Medical Evaluation Manager in the Case Management team within Global Safety and Pharmacovigilance (GSPV). You will oversee the timely delivery of high-quality medical evaluations by our vendor, train Medical Evaluators, provide guidance on complex cases and establish assessment frameworks. Through this work, you will help ensure the quality of our Individual Case Safety Reports (ICSRs).
Working across functions, you will help shape our global medical evaluation strategy, address challenges and drive process improvements. Ready to bring your medical expertise and collaborative approach to our global case management team? We would love to hear from you.
Responsibilities:
- Oversee vendor activities to ensure high-quality, timely medical evaluation and processing of individual case safety reports.
- Apply medical and scientific judgment to assess safety information, including causality, expectedness, seriousness, and clinical relevance.
- Ensure medical evaluation activities comply with pharmacovigilance regulations, company standards, and applicable SOPs.
- Contribute to continuous process improvement, including review and enhancement of safety-relevant procedures.
- Collaborate with internal GSPV functions, cross-functional stakeholders, and the vendor to ensure consistent, high-quality safety assessments.
- Deliver onboarding training or knowledge-sharing activities to vendor Medical Evaluators.
- Identify potential challenges, risks, and roadblocks associated with the global medical evaluation strategy and work as a leader in developing solutions to address these, working cross-functionally with other departments.
- Support the monitoring of vendor performance, training, workload, and issue resolution through appropriate governance and oversight.
- Respond clearly and promptly to health authority queries related to case medical evaluation.
- Identify resources and tools necessary to facilitate risks and implement necessary risk management initiatives.
- Interface with key high-level internal and external stakeholders, contribute to and approve regulatory reports, submissions, and responses to queries.
Education:
- Advanced Medical/Pharmacy Degree (e.g., MD or PharmD) or international equivalent.
Experience:
- Seven (7) years of pharmaceutical/CRO industry experience, a significant proportion of which should be in a medical evaluation role, with a broad overview of all aspects of a PV system and specific experience with regulatory requirements.
- Experience in the medical assessment of complex biologic products, including vaccines and combination products, is desirable.
Competencies:
- Deep knowledge of PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, and ICSR management) and how safety decisions can impact other functions and patients.
- Experience and success in addressing and managing complex medical issues in pre-approval and post-approval environments.
- Conveying complex concepts through clear and concise messages.
- Demonstrating two-way communication by seeking and incorporating feedback to improve output and alignment.
- Providing appropriate direction, gaining commitment, developing, and empowering others.
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 scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
Medical Evaluator in Melbourne employer: CSL
CSL is an exceptional employer that fosters a collaborative and innovative work culture, making it a leader in the biotechnology sector. With a strong commitment to employee growth, CSL offers extensive professional development opportunities and the chance to work on impactful projects across the Asia Pacific region. Located in Australia, employees benefit from a supportive environment that values diversity and inclusion, ensuring a rewarding career path in a company dedicated to saving lives.
