Sonia Ahmad

About Sonia Ahmad

Medical and Pharmacovigilance professional with over 7 years of cumulative experience in…

Experience

1. Drug Safety Associate (through Jun 2024)

   Parexel

   Mar 2021 — Present · Newton, MA, US

   Performed drug safety management (clinical trial and post-marketed) by providing process related support including case intake, book in, medical triage, validity assessment, data entry, data coding, narrative writing, quality review, and medical monitoring activities, ensuring compliance with relevant regulations and standard operating procedures (SOPs). • Maintained a good working knowledge of the adverse event safety profile of the assigned drugs, client’s guidelines, SOPs, and global drug safety regulations. • Triaged and monitored incoming reports from various sources including mailboxes, literature searches, etc. for completeness, legibility, and validity. • Experienced case processor on safety databases for accurate data capture, concise narratives with quality checks, data reconciliation, follow-up, and query management, as applicable. Ensured that the expectedness, causality assessment, and seriousness criteria were accurate for the events. Trained new team members.• Ensured MedDRA coding in accordance with “MedDRA Term selection: Points to Consider” and WHO-DD coding principles.• Maintained an awareness of global regulatory reporting obligations and organized work to ensure compliance with internal and regulatory timelines for the adverse event reporting.

Education

• University of Health Sciences. Allama Iqbal Medical College, Lahore, Pakistan.

  Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine

  2004 — 2010

• The University of North Carolina at Chapel Hill

  Master of Public Health - MPH, Public Health Leadership Program

  2017 — 2019