Global Medical Evaluation Lead - Case Management

CSL; Melbourne; On-site; AUD 180,000 - 240,000; Full time

Job summary

CSL is seeking a Medical Evaluation Manager within Global Safety and Pharmacovigilance (GSPV). You will oversee timely, high-quality medical evaluations conducted by our vendor, mentor Medical Evaluators, and shape assessment frameworks to support robust ICSR quality.

Reporting across functions, you will drive global medical evaluation strategy, address challenges, and lead cross-functional collaboration to deliver compliant, evidence-based safety assessments in a dynamic, global environment.

Qualifications

• Seven years in pharmaceutical/CRO with medical evaluation focus.
• PV system concepts and regulatory requirements experience.
• Experience evaluating complex biologics, vaccines, and combination products is desirable.

Responsibilities

• Oversee vendor activities to ensure high-quality medical evaluation and processing of ICSRs.
• Apply medical and scientific judgment to assess safety information (causality, expectedness, seriousness, clinical relevance).
• Ensure medical evaluation activities comply with pharmacovigilance regulations, company standards, and SOPs.
• Collaborate with internal GSPV functions, cross-functional stakeholders, and the vendor for consistent safety assessments.
• Deliver onboarding training to vendor Medical Evaluators.
• Identify challenges, risks, and roadblocks in the global medical evaluation strategy and lead cross-functional solutions.
• Support monitoring of vendor performance, training, workload, and issue resolution via governance.
• Respond to health authority queries related to case medical evaluation.
• Identify resources/tools to facilitate risk management initiatives.
• Interface with key stakeholders and contribute to regulatory reports and responses.

Skills

Vendor management

Medical evaluation

Regulatory compliance

Causality assessment

Leadership

Cross-functional collaboration

Training/mentoring

Process improvement

Communication

Education

MD or PharmD or international equivalent

Job description

CSL is seeking a Medical Evaluation Manager within Global Safety and Pharmacovigilance (GSPV). You will oversee timely, high-quality medical evaluations conducted by our vendor, mentor Medical Evaluators, and shape assessment frameworks to support robust ICSR quality.

Reporting across functions, you will drive global medical evaluation strategy, address challenges, and lead cross-functional collaboration to deliver compliant, evidence-based safety assessments in a dynamic, global environment.