Rincy Roy
Kollam
Summary
Experienced Drug Safety Associate with 5 years in the pharmaceutical industry, skilled in adverse event case processing, regulatory compliance, and drug safety operations. Seeking a challenging position to leverage my skills and contribute to the organization’s growth through hard work and commitment.
Overview
7
7
years of professional experience
Work History
Pharmacy Assistant
Shoppers Drug Mart
Peterborough
12.2023 - 05.2025
- Receive and process prescription orders accurately and efficiently.
- Prepare and label medications according to prescription orders and ensure proper dosage and quantity.
- Assist pharmacists in inventory management, including ordering and restocking medications and supplies.
- Maintain a clean and organized pharmacy environment, including proper storage of medications and disposal of expired drugs.
- Collaborate with pharmacy team members to ensure smooth workflow and adherence to pharmacy policies and procedures.
- Proficient in pharmaceutical and medical terminologies, including drug classifications and common healthcare abbreviations.
- Knowledgeable in medical insurance-related terminology such as deductibles, copayments, and prescription adjudication processes.
Pharmacy Assistant
Greg’s No Frills
Peterborough
12.2022 - 09.2023
- Receive and process prescription orders accurately and efficiently.
- Prepare and label medications according to prescription orders and ensure proper dosage and quantity.
- Assist pharmacists in inventory management, including ordering and restocking medications and supplies.
- Maintain a clean and organized pharmacy environment, including proper storage of medications and disposal of expired drugs.
- Collaborate with pharmacy team members to ensure smooth workflow and adherence to pharmacy policies and procedures.
- Committed to maintaining confidentiality and privacy in all aspects of healthcare system.
Operation Specialist – Pharmacovigilance
IQVIA RDS Pvt Ltd
Kochi
11.2020 - 10.2022
- Managed pharmacovigilance activities, including AE intake, triage, ICSR case processing, literature screening, and follow-up using Sapphire and Argus databases.
- Conducted medical evaluation of AE cases, assessing seriousness, expectedness, and causality.
- Performed duplicate checks, narrative writing, MedDRA and WHODrug coding, and case quality review.
- Analyzed cumulative AE data and trends to identify potential safety signals; escalated findings to medical review teams.
- Prepared aggregate reporting data for PSURs/PBRERs, DSURs, and PADERs including line listings, summary tabulations, and cumulative analyses.
- Ensured compliance with ICH, GCP, FDA, EMA, EU and Health Canada PV guidelines.
- Conducted quality reviews of cases processed by junior associates to ensure accuracy and completeness.
- Provided training sessions on recent updates in the process and answered queries of case processors.
- Generated and managed regulatory report forms (MedWatch/CIOMS/E2B) for submission to authorities.
- Maintained confidentiality and privacy in all aspects of healthcare system.
Drug Safety Associate II
Bioclinica Pvt Ltd
Mysore
04.2018 - 10.2020
- Performed Pharmacovigilance activities for Baxter (renal drugs and devices, oncology, and other therapeutic areas) using ARISg database in compliance with SOPs and regulatory guidelines.
- Responsible for adverse event case processing including unsolicited, solicited, patient support programs, E2B, legal, line listings, and social media cases.
- Led safety activities for assigned clinical trials, ensuring adherence to all PV requirements.
- Conducted QC reviews of case processing and safety database entries performed by associates for accuracy and completeness.
- Reviewed and ensured the quality of patient narratives and regulatory report forms.
- Generated and managed regulatory report forms (MedWatch/CIOMS/E2B) for submission to authorities.
- Conducted adverse event and drug coding using MedDRA and WHODrug, and prepared safety narratives.
- Maintained confidentiality and privacy in all aspects of healthcare system.
Education
Pharmacy Technician -
Fleming College
Peterborough, ONDoctor of Pharmacy (Pharm.D) -
Tamil Nadu MGR University
Chennai, IndiaSkills
- Argus
- ARISg
- Sapphire databases
- MedDRA
- WHODrug
- Kroll
- Healthwatch pharmacy software
- PointClickCare EMR
- MS Office
- Good Documentation Practices
- Quality Management Systems
- ICH GVP
- FDA guidelines
- EMA guidelines
- Health Canada guidelines
Languages
Malayalam
First Language
English
Beginner
A1
Hindi
Upper Intermediate
B2
Timeline
Pharmacy Assistant
Shoppers Drug Mart
12.2023 - 05.2025
Pharmacy Assistant
Greg’s No Frills
12.2022 - 09.2023
Operation Specialist – Pharmacovigilance
IQVIA RDS Pvt Ltd
11.2020 - 10.2022
Drug Safety Associate II
Bioclinica Pvt Ltd
04.2018 - 10.2020
Pharmacy Technician -
Fleming College
Doctor of Pharmacy (Pharm.D) -
Tamil Nadu MGR University