Arthika Thirunavukkarasu
Oakville,Canada
Summary
Detail-oriented and highly motivated Drug Safety Associate with experience in Pharmacovigilance, Quality Assurance, and Regulatory Compliance. Currently pursuing Regulatory Affairs & Quality Operations (Co-op) at Fanshawe College, seeking a Clinical Research Coordinator (Co-op) position to apply my skills in laboratory operations, clinical data management, and regulatory processes. Strong background in ICH/GCP guidelines, patient recruitment, SOP and clinical trial documentation.
Overview
4
4
years of professional experience
4
4
Certification
Work History
Drug Safety Associate
Accenture
03.2021 - 04.2023
- Conducted thorough case processing and triaging of adverse drug reactions (ADRs) to ensure timely and accurate reporting to regulatory authorities
- Managed Individual Case Safety Reports (ICSRs) and ensured compliance with global pharmacovigilance guidelines
- Performed literature screening to identify potential drug safety signals and contributed to safety surveillance activities
- Monitored safety data to detect signals, assess trends, and supported risk-benefit analyses for marketed products
- Participated in internal and external pharmacovigilance audits, ensuring regulatory compliance and readiness for inspections
- Prepared safety documentation including clinical study reports, safety summaries, and safety data sheets (SDS)
Quality Assurance Associate
Madras Pharma
02.2019 - 12.2020
- Conducted quality inspections on pharmaceutical packaging and ensured proper safety checks prior to production start-up
- Performed in-process testing such as PH and visual inspections during bulk filling stages
- Verified primary and secondary packaging components, ensuring compliance with regulatory and safety standards
- Documented all packaging activities in Manufacturing Batch Production Records (MBPR) with accuracy and timeliness
- Collaborated with the production team to address potential quality issues and implemented hold procedures for suspect products
- Assisted in creating and updating Standard Operating Procedures (SOPs) to enhance operational efficiency
Education
Regulatory Affairs And Quality Operations (CO-OP) -
Fanshawe College
Toronto, ON08.2025
Bachelor of Pharmacy -
Swamy Vivekanandha College of Pharmacy
Namakkal, India04.2017
Skills
- Clinical Research Coordination
- Regulatory Compliance
- calibration and performing diagnostic tests
- Strong organizational skills
- Time management skills
- Data collection
- Source documentation
- Database management
- Proficient in MS Office Suite
- Site management
- Competency in technical writing (SOPs, Annual Reports, Investigation Summaries)
Certification
- Pharmaceutical Industry Drug Regulatory Affairs (DRA) - UDEMY
- Pre-Market Regulation for Medical Device - Health Canada
- SQL Bootcamp
- WHMIS
Timeline
Drug Safety Associate
Accenture
03.2021 - 04.2023
Quality Assurance Associate
Madras Pharma
02.2019 - 12.2020
Regulatory Affairs And Quality Operations (CO-OP) -
Fanshawe College
Bachelor of Pharmacy -
Swamy Vivekanandha College of Pharmacy
Similar Profiles
Amanjot Kaur LambaAmanjot Kaur Lamba
Workday Integration Consultant at AccentureWorkday Integration Consultant at Accenture
Sumit PatilSumit Patil
SAP Security and GRC Consultant at AccentureSAP Security and GRC Consultant at Accenture
Sajal BhardwajSajal Bhardwaj
People Advisor Analyst, HRBP at AccenturePeople Advisor Analyst, HRBP at Accenture
Priyanka GhoshPriyanka Ghosh
Instructional Design Analyst at AccentureInstructional Design Analyst at Accenture
Lucy VieiraLucy Vieira
Vice President, Away by TTI Travel & New Talent Development, 2018-2023 Director, Away by TTI Travel & The Circle, 2009-2018 at TTI TRAVELVice President, Away by TTI Travel & New Talent Development, 2018-2023 Director, Away by TTI Travel & The Circle, 2009-2018 at TTI TRAVEL