Manisha Pathak
Pune
Summary
Dedicated and consistent pharmacovigilance associate with 2.3 years of experience in ICSRs received from spontaneous, post marketing studies, regulatory, and license partner reports. I have a hands-on experience on case validity assessment, database entry, event selection and coding using MedDRA, product coding, seriousness, causality, labelling documents, writing narratives, medical input, and argus safety database. I have good knowledge of special case scenarios and the lack of efficacy reports. I also have 1.1 years of experience as a medical scribe, and gained a good knowledge of medical terminologies and EHR handling.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Senior Process Executive
Cognizant Pvt. Ltd.
06.2023
- Record patient histories, physical exams, assessments, and treatment plans in real-time
- Ensure accurate and timely entry of patient information into electronic health records EHR
- Accompany healthcare providers during patient encounters to document details and orders
- Facilitate communication between healthcare team members and patients as needed
- Organize and maintain patient records in compliance with regulatory standards.
Junior Associate - Pharmacovigilance
Indegene
03.2021 - 06.2023
- Enter and verify clinical and safety data into pharmacovigilance databases accurately and promptly
- Review ICSRs for completeness, accuracy, and consistency, ensuring adherence to regulatory guidelines (e.g., ICHGCP, FDA, EMA
- Assist in signal detection activities by identifying potential safety concerns or trends in adverse event reports
- Assign appropriate medical coding (e.g., MedDRA, WHODD to adverse events and medical history terms
- Collaborate with stakeholders such as medical monitors, regulatory affairs, and clinical teams to resolve queries and ensure timely reporting
- Maintain detailed records and documentation of all actions taken in compliance with pharmacovigilance regulations.
Education
Bachelors of Engineering in Biotechnology -
SSBT, COET
Jalgaon, Maharashtra11.2020
High School Diploma -
Dr. Junior College
Nandurbar, Maharashtra06.2015
Skills
- Pharmacovigilance
- Quality Assurance
- MedDRA
- Basic knowledge of aggregate reporting
- PBRER/PSUR
- DSUR
- PADER
- Aggregate reporting
- Argus Safety
- ICSR
- Medical terminology
- EHR proficiency
- Microsoft Excel
- Microsoft Word
Certification
- Pharmacovigilance Aggregate Reporting - Udemy
- Completed PG-diploma in clinical research - Clariwell Global Services
Languages
English
Marathi
Hindi
Accomplishments
Received 7 awards, namely as Going the extra mile, Hitting the mark, Double-up, Best Sprinter and three times Make it happen for consistency, quality outputs, process improvements and dedication towards work.
Internships and trainings
- Gene Cloning and Protein Synthesis - Central Dogma, Pune
- Industrial Training - Lupin Pharmaceuticals, Vadodara
Timeline
Senior Process Executive
Cognizant Pvt. Ltd.
06.2023
Junior Associate - Pharmacovigilance
Indegene
03.2021 - 06.2023
Bachelors of Engineering in Biotechnology -
SSBT, COET
High School Diploma -
Dr. Junior College
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