Aswathi M c

Pharm.D professional with 5 years of hands-on experience in pharmacovigilance operations, specializing in Individual Case Safety Reports (ICSRs), quality review, and medical narrative writing. Currently serving as Operations Specialist I at IQVIA, with proven expertise in case processing and compliance with global regulatory guidelines (EMA, MHRA, FDA).

Operations Specialist I at IQVIA (2021-05 – Present)

• Performing detailed quality Checks(QC) for accuracy, completeness and medical relevance.
• Strong command of MedDRA and WHO DD coding for adverse event, medical history and product data.
• Provide quality feedback to team resource.
• Track and maintain quality metrics.
• End to end Individual Case Safety Reports (ICSRs) ensuring compliance with global regulatory and client-specific requirement.
• Familiar ARISg 7.4.4.0.8 and LSMV database.
• Ensuring consistency of case narrative and medical coherence across all fields.
• Case evaluation and medical assessment aligned with clinical judgment.
• Reviewing Causality, Seriousness and expectedness.
• Conducting duplicate searches, follow-up and case reconciliation activities.

Doctor of Pharmacy in Pharm.D – Kerala University of Health and science (2014-09 – 2020-10)