Pharmacovigilance Executives/Specialists

Roles & Responsibilities
• Perform end-to-end ICSR processing from spontaneous, clinical, literature, and solicited sources
• Handle case intake, triage, data entry, MedDRA and WHO-DD coding, narrative writing, QC, and follow-ups
• Conduct systematic literature surveillance and generate compliant literature ICSRs
• Ensure timely regulatory submissions to global health authorities (USFDA, EMA, MHRA, PMDA, etc.)
• Support aggregate safety reports including PSUR, PBRER, and DSUR
• Maintain compliance with global PV regulations, internal SOPs, and client procedures
• Support internal, client, and regulatory audits including CAPA activities
• Assist in signal detection and ongoing safety data review
• Perform regulatory intelligence and safety trend monitoring
• Collaborate with cross-functional and client teams in a consulting environment

Qualification
• Graduate or Postgraduate in Life Sciences
• B.Pharm / M.Pharm / Biotechnology / Biology / Chemistry or related disciplines
• Master’s degree preferred

Experience
• 1–5 years of experience in Pharmacovigilance or Drug Safety
• Experience in global PV projects and regulatory submissions preferred

Skills
• Hands-on experience with safety databases such as Argus, ArisG, Veeva, or similar
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP, USFDA, EMA, MHRA)
• Excellent communication, analytical, and documentation skills
• Ability to work in a fast-paced consulting and client-facing environment

About the Organisation
Amarant Lifesciences Private Limited is a regulatory and pharmacovigilance consulting organization providing end-to-end drug safety and compliance solutions to global pharmaceutical and biotechnology clients, offering strong exposure to international regulatory projects and career growth opportunities.