Senior Pharmacovigilance Associate

Roles & Responsibilities
• Lead end-to-end case processing and adverse event reporting activities
• Perform case triage, data entry, narrative writing, and MedDRA coding
• Ensure timely and compliant regulatory submissions including PSURs
• Analyze safety data and support signal detection activities
• Maintain pharmacovigilance database integrity (Argus)
• Collaborate with cross-functional teams for safety and regulatory deliverables
• Mentor junior team members and provide technical guidance
• Support audits and regulatory inspections in line with global PV regulations

Qualification
• Degree in Life Sciences / Pharmacy / Nursing or related field

Experience
• Minimum 2 years of strong Pharmacovigilance / Drug Safety experience
• Experience in ICSR processing and aggregate safety reporting preferred
• Hands-on exposure to Argus safety database

Skills
• Expertise in case triage, processing, and MedDRA coding
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP)
• Analytical thinking and safety data interpretation skills
• Strong written and verbal communication abilities
• Ability to work in a hybrid and cross-functional environment

About the Company
ICON plc is a global clinical research organization delivering outsourced development and commercialization services to pharmaceutical, biotechnology, and medical device companies. With a strong commitment to patient safety and regulatory excellence, ICON offers structured career growth, global exposure, and opportunities to contribute to innovative drug safety programs worldwide.