Medical Evaluator - Global Case Management

CSL; King of Prussia (PA); On-site; USD 130,000 - 180,000; Full time

Job summary

CSL is seeking a Medical Evaluation Manager to lead the Case Management team within Global Safety and Pharmacovigilance. You will supervise vendor medical evaluations, train Medical Evaluators, and shape the global medical evaluation strategy to ensure ICSRs are high quality.

You will collaborate across functions, drive process improvements, and respond to health authority queries while guiding risk management and regulatory submissions.

Qualifications

• Advanced medical or pharmacy degree required.
• 7+ years in pharmaceutical/CRO with medical evaluation exposure.
• Experience with PV system regulatory requirements.
• Experience in medical assessment of biologics, vaccines desirable.

Responsibilities

• Oversee vendor activities to ensure high-quality, timely medical evaluation and processing of ICSRs.
• 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.
• 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.

Skills

PV concepts

Causality assessment

Regulatory knowledge

Medical communication

Leadership

Education

MD or PharmD

Job description

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.