Medical Evaluation Manager
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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.