Pharmacovigilance Associate

Pharmacovigilance Associate- Post-Marketing case processing

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization's commitment to patient safety and compliance.

Must Have Criteria:

• Minimum 2 years of experience in safety background, with direct involvement in case processing

• Must have solid experience in Post Marketing Surveillance case processing

• Bachelors in B.Pharm, M.Pharm, Pharm.D, BDS, BSc. Nursing, MSc. Nursing, BAMS, BHMS

What You Will Be Doing:

• Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
• Partner with cross-functional teams to address safety-related questions and support ongoing investigations
• Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards
• Manage safety inbox and acknowledge case receipt.
• Perform case triage and book-in to safety database.
• Enter case details accurately and write narratives.
• Code events, drugs, and medical history using MedDRA/WHO-DD.
• Apply correct product labeling and perform QC checks.
• Finalize case processing and generate queries for follow-up
• Knowledge of seriousness, expectedness, causality, and global reporting
• Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR)
• Ability to mentor new joiners and review SOPs
• Working knowledge of SDEA and KPI/SLA basics
• Process literature ICSRs and maintain compliance with monitoring requirements

Your Profile:

• Must have 2+ years in PV Case processing in Post Marketing
• Strong analytical skills with attention to detail in data collection and reporting
• Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders
• A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities

What ICON can offer you:

Visit our to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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