Sahil Sharma

Contract role at a pharmaceutical manufacturing and corporate facility. Prepare incident documentation and handle confidential information under site compliance procedures.

Support prescription processing in Kroll and day-to-day pharmacy workflow.

Processed prescriptions in HealthWatch including insurance adjudication, supported dispensing under provincial regulations and SOPs, managed inventory and expiry monitoring, and handled personal health information under strict confidentiality.

Led a global team of 10+ medical writers, improving on-time delivery of aggregate safety reports by 25% and reducing QC findings by 15%. Owned client programs end-to-end, including content strategy, review scheduling, and submission readiness.

Cut submission cycle time by 20% across DSUR, RMP, CSR, protocol and narrative deliverables by standardizing templates and authoring conventions. Led Phase I-IV clinical and safety documents in a global matrix, coordinating cross-functional contributions.

Authored and QC-reviewed submission-ready PBRERs/PSURs, DSURs, PADERs and Addenda to Clinical Overviews for FDA, EMA and Health Canada. Supported eCTD dossier preparation and literature surveillance.

Delivered PBRERs/PSURs and DSURs to global sponsor deadlines by processing and reconciling ICSR data in Argus with MedDRA coding. Supported signal detection and safety topic reviews, and maintained audit and inspection readiness.

Graduate Certificate in Project Management from Algonquin College, Canada, completed from 2023 to 2024.

Postgraduate Certificate in Business Administration from York University, Canada, completed from 2022 to 2023.

Master of Science in Pharmacy with specialization in Pharmacoinformatics from NIPER Hajipur, India, completed from 2013 to 2015.

Bachelor of Pharmacy in Pharmaceutical Sciences from Panjab University, India, completed from 2009 to 2013.