CSL

Director, Medical Evaluation – Case Processing Oversight

CSL

full-time

Posted on:

Location Type: Office

Location: King of Prussia • Pennsylvania • United States

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Job Level

Lead

About the role

  • Oversees all areas of single case processing in the global pharmacovigilance database from all sources
  • Ensures that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs
  • Responds to specific questions or queries about cases
  • Develops standards and processes, with a focus on global compliance and process optimization
  • Oversees Medical Evaluators responsible for medical review of ICSRs

Requirements

  • Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
  • 5 years of managerial/leadership experience
  • Global pharmacovigilance database knowledge is required
  • Proficient knowledge of global and local regulatory rules and regulations
  • BS/BA, RN, Pharmacist, or similar
Benefits
  • Health insurance
  • 401(k) matching

Applicant Tracking System Keywords

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

Hard skills
pharmacovigilancecase processingregulatory guidelinesprocess optimizationmedical reviewclinical trial experiencepost-marketing experienceglobal compliance
Soft skills
managerial experienceleadership
Certifications
BSBARNPharmacist