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To pursue a challenging career and be a part of progressive organization that gives scope to enhance my knowledge and skills, which can be used for the organizational and personal growth.
Roles and Responsibilities:
Aug-2018 to present: Pharmacovigilance Specialist @ Med Communications, Inc.
Integrate scientific expertise with knowledge of safety database functions to ensure comprehensive case entry and identification of follow up requirements.
Accurate case entry in the safety database.
Complete medical literature search activities for pharmacovigilance purposes.
Create and review ad hoc reports.
Interact with Pharmacovigilance Physician for case management follow and medical review and scientific information exchange pertaining to pharmacovigilance activities.
June 2015 – Oct 2017: - Global Safety & Pharmacovigilance Associate @ inVentiv International Pharma Services Pvt. Ltd
Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from articles, with emphasis on timeliness and quality.
Ensure accurate and consistent coding of medical history, drugs and adverse event terms.
Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling.
Screen literature articles for data basing or rejection.
Identification of one or more valid ICSR qualifying for data entry into the Argus safety database and ensuring that the articles rejected do not contain valid ICSRs, per the guidelines.
June 2013 – June 2015: - Process Analyst @ Accenture Services Pvt. Ltd
Reported adverse events to FDA according to ICH guidelines related to (post-marketed) litigation drugs/vaccines.
Managed timely case processing to ensure PSUR deadlines.
Managed the initial assessment and distribution of adverse event triage case assignments to the pharmacovigilance group
Created comprehensive narratives procured from relevant, related information from various source documents.
Generated requests for follow-up information.
Provided follow-up on adverse event cases by preparing, sending out and tracking queries to reporters.
Aggregate (in %)
Month, Year of Passing
M Pharmacy (Pharmaceutics)
T John College of Pharmacy, Bangalore
HSK College of Pharmacy, Bagalkot (Karnataka)
Intermediate (12th Class)
Board of Intermediate Education, Andhra Pradesh
Board of Secondary Education, Andhra Pradesh
Title: Design and Evaluation of Anticholesterimic Drug – Niacin in combination with Guar Gum in extend release dosage form.
Pharmacovigilance, Quintiles, Bangalore
Designation: Drug Safety Associate:
Contribution and Outcomes:
A team player who has been exposed to and had to act on corresponding activities of the Argus Database, Volume 9A, GCP Guidelines, Clinical trials.