Jibin Joji Varghese
Ballycullen,Ireland
Summary
Accomplished professional with extensive expertise in pharmacovigilance and drug safety analysis, specialising in end-to-end ICSR processing and management. Demonstrates proficiency in adverse event reporting, MedDRA coding, and safety narrative writing, ensuring regulatory compliance and inspection readiness. Skilled in utilising ARGUS Safety Database and ARISg Database for effective case processing and documentation accuracy. Strong analytical thinker with a keen attention to detail, adept at patient safety monitoring, risk assessment, and quality review. Committed to process improvement and team collaboration within fast-paced environments while maintaining effective communication with clients and stakeholders.
Overview
6
6
years of professional experience
1
1
year of post-secondary education
1
1
Certification
Work history
Home support worker
Comfort Keepers
Dublin, Ireland
2025.05 - Current
- Providing care and support to the clients based on their care support plan.
Senior Drug Safety Associate
Accenture
Chennai, India
2022.06 - 2024.12
- Conduct detailed intake and assessment for spontaneous and Phase IV cases using ARISg, covering diverse case types such as market research, business partner, and patient support program cases.
- Perform accurate duplicate searches to ensure case uniqueness and determine whether cases should be classified as initial or follow-up based on medical and temporal relationships.
- Complete comprehensive data entry within the ARISg database, including patient details, reporter information, product details, event coding, seriousness assessment, and causality assessment.
- Maintain a high level of accuracy and attention to detail in the documentation and classification of adverse event reports.
- Demonstrate strong proficiency in using the ARISg database for efficient and accurate case management.
- Ensure compliance with all relevant regulatory guidelines and internal pharmacovigilance procedures.
- Communicate clearly and effectively with clients, providing updates and clarifications as required.
- Contribute to team performance by sharing insights and supporting continuous improvement in case handling processes.
- Maintain up-to-date professional knowledge in pharmacovigilance practices and database management.
- Demonstrate strong organizational skills by effectively managing and prioritizing multiple tasks in a fast-paced work environment.
Jr Drug Safety Associate
Bioclinica
Mysore, India
2020.02 - 2022.02
- Perform end-to-end ICSR processing (full case processing), including both serious and non-serious, solicited and spontaneous cases.
- Full case processing of legal cases, social media cases, regulatory cases, literature cases, cases from studies etc.
- Demonstrate proficiency in literature case processing, ensuring high standards of data quality and accuracy.
- Accurately enter adverse event data into the Argus database, including patient details, event coding, seriousness assessment, and product information.
- Ensure complete and accurate case documentation, with a strong focus on clinical and non-clinical event coding and product coding.
- Conduct duplicate checks, assign appropriate actions, and initiate follow-up queries in line with project-specific requirements.
- Manage case scheduling, including marking reports for submission or non-submission, and ensure timely transmission of individual and bulk reports in compliance with protocols.
- Handle rapid notification transmission for serious cases, ensuring timely and accurate processing.
- Assign untranslated source documents for translation via the TransPerfect portal and manage the attachment of translated documents to cases.
- Perform data verification (quality checks) of processed ICSRs to maintain accuracy and compliance.
- Author clear and comprehensive case narratives for a wide range of serious cases, including clinical trials, literature, and regulatory authority reports.
- Communicate effectively with clients, participating in project-related discussions and ensuring clear understanding of requirements.
- Support project management activities, including documentation and email communication, to ensure smooth project execution.
- Contribute to team training and continuous improvement by promoting quality standards and best practices.
Education
MSc in Pharmaceutical Business & Technology - Pharmaceutical
Griffith College Dublin
Ireland 2025.02 - 2026.06
Doctor of Pharmacy - Clinical Pharmacy
Rajiv Gandhi University of Health Sciences
India /2013 - /2019
Skills
Pharmacovigilance & Technical Expertise
- Pharmacovigilance and Drug Safety Analysis
- End-to-End ICSR Processing and Management
- Adverse Event Reporting (Serious & Non-Serious; Solicited & Spontaneous)
- MedDRA Coding and WHO-DD Product Coding
- Safety Narrative Writing
- Literature Case Processing
- Regulatory Reporting and Compliance
- Patient Safety Monitoring and Risk Assessment
- Data Verification and Quality Review
- Clinical Trial Protocol Understanding
- ARGUS Safety Database
- ARISg Database
- TransPerfect (Translation Management)
- Microsoft Office Suite (Excel, Word, Outlook)
- Case Processing and Documentation Accuracy
- Regulatory Compliance and Inspection Readiness
- Project Coordination and Support
- Client Communication and Stakeholder Engagement
- Process Improvement and Team Contribution
- Strong Attention to Detail
- Analytical Thinking and Problem-Solving
- Time Management and Prioritisation
- Team Collaboration
- Adaptability in Fast-Paced Environments
- Effective Communication Skills
Affiliations
- Singing
- Listening to music
- Watching movies
- Other similar activities
Certification
QQI Level 5 modules in Care Skills & Care of The Older Person.
Accomplishments
Encore Awards 2024/Star of Business Award by Accenture for the period of Q2, FY24 in recognition of my efforts towards creating client value through business outcomes.
Timeline
Home support worker
Comfort Keepers
2025.05 - Current
MSc in Pharmaceutical Business & Technology - Pharmaceutical
Griffith College Dublin
2025.02 - 2026.06
Senior Drug Safety Associate
Accenture
2022.06 - 2024.12
Jr Drug Safety Associate
Bioclinica
2020.02 - 2022.02
Doctor of Pharmacy - Clinical Pharmacy
Rajiv Gandhi University of Health Sciences
/2013 - /2019