Manisha Pathak
ICSR case processor| Proficient in Pharmacovigilance process I Ensure Patient safety
- Role
- Senior Process Executive at Cognizant
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Manisha Pathak
Dedicated and consistent pharmacovigilance associate with 4 years of experience in ICSRs. 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 worked as a case processor, quality reviewer, and case triage.
Experience
Senior Process Executive
Jun 2023 — Present · Pune, IN
Initial Assessment and Triage: Reviewing adverse event reports to determine their validity, severity, and regulatory reporting requirements.Data Entry and Management: Ensuring accurate data entry of adverse event details into a pharmacovigilance database or reporting system.Case Prioritization: Determining which cases need immediate attention or further investigation, such as those involving serious adverse events (SAEs) or new safety signals.Follow-up and Documentation: Coordinating with healthcare professionals or reporters for additional information if necessary.Compliance and Reporting: Ensuring the timely submission of safety reports to regulatory authorities, in accordance with local and global regulations.Collaboration: Working closely with the pharmacovigilance team, medical reviewers, and regulatory affairs to ensure thorough review and compliance.
Education
Dr. Junior college Nandurbar
HSC, Physical Sciences
North Maharashtra University
Bachelor's of Engineering, Biotechnology
Clariwell Global Services
PG-diploma in clinical research, clinical research
2020 — 2021
Dr. Kane Girls High school
SSC, General Studies
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