Sobyga Ravikumar

Dedicated Pharmacovigilance professional with 3+ years of Drug Safety experience within the Canadian pharmaceutical environment, handling end-to-end AE collection, processing, triage, narrative writing, reporting, reconciliation, and compliance tracking. Experienced in supporting QMS activities, SOP/WI development, CAPA processes, and audit readiness. Strong knowledge of Health Canada GVP regulations and GxP standards.

Bilingual Drug Safety Associate (QC) - Cencora – Innomar Strategies - QC

(2022-06)

• Manage AE workflows and perform triage of 70+ cases daily.
• Perform seriousness assessment, causality analysis, and narrative writing.
• Prepare weekly and monthly reconciliation reports.
• Ensure 100% compliance with SOPs, training, and regulatory requirements.
• Support CAPA and non-conformance processes.
• Maintain audit readiness through accurate documentation and controlled archiving.
• Assist in SOP and Work Instruction review and updates.

Microbiology Technician (QC) - Neopharm Labs Inc. - QC

(2021-07 - 2022-06)

• Performed microbiological USP assays and water analysis.
• Ensured precise documentation and GxP compliance.

COVID-19 Specimen Processing Technician - Dynacare - QC

(2021-04 - 2021-07)

• Achieved 100% accuracy in specimen labeling and data management.

Research Intern – Virology Lab - National Research Institute Armand Frappier

(2020-05 - 2020-08)

• Conducted Zika virus research using reverse genetics systems.

Assistant Manager - Tim Hortons

(2017 - 2021)

• Managed operations, scheduling, and customer service.

PgDip - Drug Development - Université de Montréal (2022)

BSc - Biochemistry & Molecular Medicine - Université de Montréal (2021)

DEC - Health Science - Dawson College (2016)