CSL

Director, Medical Evaluation – Case Processing Oversight

CSL

full-time

Posted on:

Location Type: Office

Location: Maidenhead • United Kingdom

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Job Level

Lead

About the role

  • Oversees all areas of single case processing in the global pharmacovigilance database
  • Ensures vendor case processing in accordance with regulatory guidelines
  • Develops standards and processes for global compliance
  • Oversees Medical Evaluators responsible for medical review of ICSRs
  • Reviews seriousness, listedness, and causality assessments
  • Drives department-wide planning, resource, budget, and strategy
  • Prepares for inspections and leads transformation initiatives
  • Aligns with Clinical, QA, Regulatory, and Safety Science functions

Requirements

  • Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
  • 5 years of managerial/leadership experience
  • Global pharmacovigilance database knowledge
  • Proficient knowledge of global and local regulatory rules and regulations
  • BS/BA, RN, Pharmacist, or similar
Benefits
  • Health insurance
  • Pension scheme
  • Flexible working hours
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
pharmacovigilancecase processingregulatory compliancemedical reviewseriousness assessmentlistedness assessmentcausality assessmentclinical trialspost-marketing surveillancebudget management
Soft skills
leadershipstrategic planningresource managementcommunicationcollaboration
Certifications
BSBARNPharmacist