Sobyga Ravikumar
Hybrid-Eligible
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About
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.
Experience
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.
Education
PgDip - Drug Development - Université de Montréal (2022)
BSc - Biochemistry & Molecular Medicine - Université de Montréal (2021)
DEC - Health Science - Dawson College (2016)