Global Medical Evaluation Lead – Case Management

CSL; King of Prussia (PA); Sur place; USD 130 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

PV concepts

Causality assessment

Regulatory knowledge

Medical communication

Leadership

Formation

MD or PharmD

Description du poste

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.