Summary
Overview
Work History
Education
Skills
Languages
Accomplishments
Timeline
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BHAVANA REPALLE

Machilipatnam

Summary

Detail-oriented Junior Associate in Regulatory Affairs & Pharmacovigilance with over 01 year of experience, adept at monitoring PV activities, addressing PQCs, AEs, inquiries, and reconciliations in coordination with service providers. Proficient in drafting and submitting PADERs to the US FDA, following eCTD criteria, and handling regulatory licensing. Former Clinical Pharmacist Intern with practical experience in patient care, medical terminology, clinical pharmacology, clinical research, AE reporting, and collaborative healthcare delivery.

Overview

3
3
years of professional experience

Work History

Junior Associate in Regulatory Affairs & Pharmacovigilance (PV) – Formulation unit

Graviti Pharmaceuticals Pvt. Ltd
01.2024 - Current
  • Regulatory Licensing activity in ODLS, CDSCO & NSWS and knowledge on eCTD modules.
  • Handling of daily PV activities by coordinating with CRO.
  • Monitoring Mailbox to Address PQCs, Inquires, AEs and their follow ups
  • Review & submission of PADERs to USFDA by following eCTD guidelines in Educe software.
  • Receipt, review, maintain of PV records i.e., ICSRs, Reconciliations, Signal reports, SDEAs.
  • Communication with CRO for MICC activity, SDEAs, Deviations, CAPA, AE handling.

Clinical Pharmacist-Intern

NTR Health University, GGH
08.2022 - 07.2023
  • Aligned to OP/IP duties in departments i.e., Gen.Med., PAEDs, Psychiatry, Surgery, OB-GYN.
  • Participated in daily clinical rotations and assisted physicians in diagnosis by measuring vitals, data collection, drawing blood samples, investigations, emergencies.
  • Medication administration & Adverse event Monitoring.
  • Patient counselling on medication usage
  • Documentation of clerkship record with 300+ cases in SOAP format.

Education

Pharm D(PB)-Doctor of Pharmacy (Post Baccalaureate) - undefined

Vijaya Institute of Pharmaceutical sciences for women (JNTUK)
01.2023

B-Pharmacy - undefined

VV Institute of Pharmaceutical sciences (JNTUK)
01.2020

10+2 - BiPC

Narayana Junior College
01.2016

10th, State Board of Secondary Education - undefined

Narayana High school
01.2014

Skills

  • Pharmacovigilance
  • Regulatory Affairs
  • Clinical data management
  • Clinical Research
  • ECTD guidelines
  • ECTD publishing Tools
  • ICH - GCP guidelines
  • Regulatory Licensing
  • Reconciliation
  • Medical Terminology
  • Clinical Pharmacology
  • Microsoft Office

Languages

English
Telugu
Hindi

Accomplishments

  • Qualified in GPAT-2020 with a “NTA score of 90.879” and secured all India wide 4563 rank.
  • Qualified in AP-PGECET with 816 rank in 2020.
  • Awarded as best organizer in the Inter college fest for the year 2019.
  • Organized various college events with other students and the college management.

Timeline

Junior Associate in Regulatory Affairs & Pharmacovigilance (PV) – Formulation unit

Graviti Pharmaceuticals Pvt. Ltd
01.2024 - Current

Clinical Pharmacist-Intern

NTR Health University, GGH
08.2022 - 07.2023

Pharm D(PB)-Doctor of Pharmacy (Post Baccalaureate) - undefined

Vijaya Institute of Pharmaceutical sciences for women (JNTUK)

B-Pharmacy - undefined

VV Institute of Pharmaceutical sciences (JNTUK)

10+2 - BiPC

Narayana Junior College

10th, State Board of Secondary Education - undefined

Narayana High school

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