Anagha Robinson
Toronto,ON
Summary
Detail-oriented professional with a robust academic foundation in Regulatory Affairs, Pharmacy, and Project Management, complemented by practical experience in pharmacovigilance. Expertise includes safety data review, ICSR case processing, MedDRA/WHO-DD coding, and ensuring regulatory compliance. Recognized for adaptability, problem-solving abilities, and exceptional communication skills.
Overview
1
1
year of professional experience
Work History
Safety Associate
IQVIA
08.2019 - 01.2021
Pharmacovigilance / Drug Safety Experience – Academic & Training Projects
- Reviewed and processed safety data from multiple sources in compliance with regulatory standards.
- Performed ICSR (Individual Case Safety Report) case processing using Argus Safety Database.
- Conducted pharmacovigilance activities including AE tracking, endpoint determination, narrative writing, and literature-based safety reporting.
- Ensured 100% compliance with SOPs, global drug safety regulations, and project timelines.
- Maintained high levels of quality and accuracy while meeting productivity targets.
Education
Post-Graduate Certificate - Project Management
Georgian College
Toronto, ON12.2022
Post Graduate Certificate - Regulatory Affairs Sciences
Algonquin College
Perth, ON12.2021
Bachelor of Pharmacy -
JSS University
MYSURU,INDIA05.2019
Skills
- Pharmacovigilance: ICSR processing, Argus Safety, AE tracking, MedDRA/WHO-DD coding
- Regulatory Compliance: CMC, NDA/NDS, ANDA/ANDS, BLA submissions
- Clinical Trials: Protocol & ICF review, CRF/eCRF, AE/SAE support
- Project Management: Gantt Charts, Project Charters, Risk Mitigation
- Software: MS Word, Excel, PowerPoint, Outlook
- Collaboration Attention to Detail Communication
- Strong knowledge of clinical trials, protocols, and regulatory frameworks
- Ability to train and support cross-functional teams
- Quick learner with proven adaptability in fast-paced environments
Timeline
Safety Associate
IQVIA
08.2019 - 01.2021
Post-Graduate Certificate - Project Management
Georgian College
Post Graduate Certificate - Regulatory Affairs Sciences
Algonquin College
Bachelor of Pharmacy -
JSS University
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