Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

Job Description:
Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations.

Required Skills:

• Bachelor’s degree in Science or a healthcare-related field.

• 4+ years of experience in Pharmacovigilance.

• Hands-on experience with ICSR processing and QC.

• Experience with Argus, ArisG, or Veeva Safety databases.

• Knowledge of MedDRA coding and FDA, ICH, and EU pharmacovigilance regulations.

• Strong communication, analytical, and documentation skills.