Shrutika Mahadik
Pimpri Chinchwad
Summary
Results-driven Junior Data Analyst with experience at Cognizant Technology Solutions, skilled in effective communication and attention to detail. Successfully executed adverse event reporting and quality reviews, ensuring compliance with pharmacovigilance regulations. Trained junior staff, enhancing team capabilities and contributing to improved case management processes.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Junior data analyst (JDA)
Cognizant technology solutions
Pune
09.2021 - Current
- Executed duplicate searches to ascertain case validity and create new cases.
- Processed serious and non-serious adverse event reports efficiently.
- Handled various report types including clinical trial, spontaneous, solicited, PMS, and regulatory authority.
- Utilized MedDRA dictionary for accurate product coding and documentation.
- Completed daily work processes within established service level agreements (SLAs).
- Transcribed all medically relevant information from source documents accurately.
- Extracted medical events and pertinent details into the drug safety database fields.
- Conducted quality reviews of cases while triaging partner submissions.
- Monitored adverse events and reported findings to regulatory authorities.
- Trained junior staff on pharmacovigilance processes and protocols.
- Contributed to the development of product labeling documents such as Core Data Sheets, Patient Information Leaflets, Summary of Product Characteristics.
- Maintained up-to-date knowledge about local and international pharmacovigilance regulations and guidelines.
- Assessed causality of reported events according to the World Health Organization criteria.
- Provided support on signal management activities such as risk assessment, root cause analysis, development of mitigation strategies.
- Performed literature searches to identify relevant published case reports or clinical studies.
Trainee Junior Data Analyst
Cognizant Technology Solutions Pvt. Ltd.
Navi Mumbai
02.2019 - 08.2021
- Monitored adverse events and reported findings to regulatory authorities.
- Reviewed and analyzed adverse event reports for accuracy, completeness, and medical relevance.
- Maintained up-to-date knowledge about local and international pharmacovigilance regulations and guidelines.
- Ensured compliance with company policies regarding adverse event handling processes.
Education
Bachelor of Pharmacy -
D.Y. Patil collage
Pimpri01.2018
Diploma in Pharmacy -
GNCOP
Sawarde01.2016
Skills
- Proactive communication
- Attention to detail
- Training and mentoring
Languages
- Hindi
- English
- Hindi
Certification
Signal Detection & Management (Udemy)
Tools
- Notepad ++
- ARGUS 8.1.2
- MEDRA dictionary 27.1
- iMedidata Rave
Timeline
Junior data analyst (JDA)
Cognizant technology solutions
09.2021 - Current
Trainee Junior Data Analyst
Cognizant Technology Solutions Pvt. Ltd.
02.2019 - 08.2021
Bachelor of Pharmacy -
D.Y. Patil collage
Diploma in Pharmacy -
GNCOP