Anita Chaudhary

Accomplished Drug Safety & Pharmacovigilance professional with 9+ years of cross-functional experience spanning CROs, pharmaceutical firms, and NGOs. Expert in end-to-end ICSR case management, SUSAR processing, causality/expectedness assessments, and global regulatory submissions (FDA, EMA). Proven track record in authoring high-quality narratives, line listings, DSURs, PSURs, and case review summaries (CRS). Adept in Argus, Nukleus, Veeva Vault, MedDRA, and WHO-DD coding. Brings additional strengths in TMF oversight, clinical documentation, and quality systems. Currently pursuing an M.S. in Clinical Research Management – Drug Safety & Pharmacovigilance at Rutgers University. Committed to elevating global patient safety through scientific rigor, compliance excellence, and data-driven signal evaluation. Seeking a Drug Safety Scientist role to drive proactive risk management and safety innovation.

• Trained in global regulatory frameworks (FDA, EMA, ICH E2E, CIOMS) and safety risk evaluation
• Practical knowledge of risk management tools (REMS/RMP), and literature surveillance, signal detection methods, including qualitative and quantitative approaches to identify and evaluate safety signals.
• Learned to interpret adverse event data and apply pharmacokinetic and pathophysiological principles to assess causality and clinical significance.
• Certifications & Training: CITI (GCP – Drugs/Devices), MSSO MedDRA (Basic & Advanced), UMC Signal Detection