Ariyan Piyush

Detail-oriented and dedicated Pharmacovigilance Associate with over 1 year of experience in abstracting, documenting, and validating clinical and safety data. Skilled in MedDRA coding, CIOMS/ICSR processing, causality assessment, and literature screening. Sound knowledge of HIPAA, ICH-GCP, GVP, and Health Canada guidelines. Proven record of maintaining ALCOA+ documentation standards and ensuring full compliance during regulatory audits and inspections.

Pharmacovigilance Associate (Formerly Research Scientist – QA & Safety) at Leuitis Pharmaceuticals LLP (CRO) (2024-12 – 2026-02)

• Delivered 100% compliance in CIOMS and ICSR submissions during partner inspections and regulatory audits.
• Supported NCQA audit readiness and quality gap closure aligned with pharmacovigilance standards.
• Abstracted, summarized, and validated patient safety information from medical records and case reports.
• Conducted causality assessments using WHO-UMC and Naranjo methods.
• Performed MedDRA coding ensuring accuracy and regulatory consistency.
• Screened scientific literature (PubMed, Sci-Hub) to identify safety data for marketed products.
• Maintained HIPAA-compliant documentation for sensitive safety information.
• Assisted in PSUR, PBRER, and RMP preparation and signal evaluation.
• Created scientific narratives meeting partner and regulatory requirements.
• Reconciled safety data with partners and supported data management projects.

Bachelor of Pharmacy in Pharmaceuticals – Indira Gandhi Institute of Pharmaceutical Sciences (2020)

Master of Pharmacy in Pharmaceuticals – Indira Gandhi Institute of Pharmaceutical Sciences (2023)

Intermediate Education in Biology, Physics, Chemistry – Regional College of Science & Technology