Officer

Perform quality review of processed ICSRs, verify data accuracy, and ensure compliance with SOPs, WIs, regulatory guidelines, and timelines. Collaborate with team members to improve quality performance and stay updated on regulatory changes.

Requirements

• 2–4 years of experience in pharmacovigilance case processing and quality review
• Strong knowledge of ICH guidelines, GVP, and global PV regulations
• Expertise in MedDRA coding, drug dictionaries, and safety databases (e.g., Argus, ARISg, Veeva)
• Excellent attention to detail, analytical skills, and ability to identify quality gaps
• Strong written and verbal communication skills in English