Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Poornima Gaddipati MD

Farmers Branch,TX

Summary

  • Physician with 5 years of PV experience in both clinical trial and post marketed products.
  • Working understanding of medical concepts and familiarity with safety activities in drug development, drug post marketing and global Regulatory authority requirements.
  • Expert in writing clinical narrative, assessing causality and expectedness using RSI.
  • Demonstrated capabilities in: Project management, Time management, Presentation skills, Strong attention to detail and organization
  • Contributed to safety sections of the Periodic safety Reports (DSUR, PBRER and PADER).
  • Performed SAE reconciliation between Clinical and Safety Database.
  • Reporting deviations and implementing CAPAs.
  • Extensive experience in the reporting as well as managing of adverse event reports.
  • Argus and ArisG safety databases.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Senior Pharmacovigilance Specialis

Pfizer
01.2021 - Current
  • Prepared metric reports pertaining to Drug Safety department for management.
  • Participated in development and maintenance of PV System policies, SOPs, work instructions, and guidance documents.
  • Participated in literature searches and assessments of scientific publications to stay informed about safety information related to Assigned products.
  • Utilized knowledge of SOP's,Working Instructions and regulations to maintain oversight of vendor activities to ensure successful Completion of tasks.
  • Performed detailed vendor oversight activities including review of metrics (KPI's), and deliverables from vendor.
  • Collaborating with other departments such as clinical research, regulatory affairs, and Quality Assurance to ensure compliance with safety regulations and guidelines.
  • Performed Root cause Analysis followed by CAPA for deviations, Suggesting issues in Quality and Compliance.
  • Alert Medical Safety Physician of potential safety issues and assisted in monitoring safety profile of products.
  • Represent and present safety and clinical data review findings during study meetings and medical safety team meetings
  • Contributed to safety sections of aggregate reports (DSUR,PBRER and PADER) by providing line listings and summary tabulations.
  • Attending Aggregate reports Strategy and Team Review Meeting.
  • Participated in signal management process (signal tracking, signal review meetings, etc.) for assigned products.
  • Contribute to development of signal detection strategy for Assigned post marketed products.
  • Continuous inspection readiness planning, as needed along with Quality Assurance Group.
  • Tracked completion of all assigned trainings by team members.

Drug Safety Specialist

Merck
05.2018 - 12.2020
  • Worked on ARISg for case processing and quality review of different types of cases.
  • Performed Medical coding using MedDRA and using WHODD in accordance with Company Coding Conventions.
  • Monitoring of drug safety inbox. generating case receipt number, Case Triage, and process adverse event reports,Writing Case Narratives,according to applicable regulations, guidelines, SOPs, and project requirements.
  • Conducted triage of incoming cases to determine seriousness for prioritization of daily workflow and classify them according to regulatory reporting Determine expectedness against appropriate labeling list.
  • Ensure duplicate check using Global Safety Database for all ICSR (Individual Case Safety reports) for existing case file.
  • Perform Case book in, Data Entry and QC of all entered data before forwarding case to next workflow.
  • Queries related to safety events are reconciled with data management team and resolved timely.
  • Performed quality control review of completed individual safety reports and ensure compliance with regulatory reporting requirements.
  • Determined and performed appropriate case follow-up, including generation of follow-up requests.

General Physician

Nalluri Multispecalty Hospital
02.2015 - 11.2017
  • Worked as Medical Doctor in ER and Wards.
  • Assisted senior physicians and surgeons during assessments, examinations, and surgical interventions.
  • Assessed and accurately diagnosed various disease conditions and provided appropriate medical intervention and treatments to all patients.
  • Reviewed and evaluated test results to suggest care and treatment options. Completed patient referrals to other medical specialists.
  • Assisted in minor and major surgical procedures, including elective caesarean session and laparotomy, herniorrhaphy, and others.
  • Performed peripheral IVs, foley catheters, oral suctioning, NG tube insertions and wound care dressing changes.

Education

MBBS (Equivalent To US MD) -

Dalian Medical University
Dalian, China.
07.2012

Skills

  • Understanding of ICH-GCP,FDA and GVP Guidelines
  • Good knowledge of US and EU pharmacovigilance regulatory requirements
  • Understanding of Medical terminology and Applied clinical judgment to interpret case information
  • Assisted in Signal Management Activities
  • Contributed to safety sections of Aggregate Reporting (DSUR, PBRER, PADER)
  • Participated in development of Safety documents such as SMP's,SOP's and working instructions
  • Providing support for audits and inspections
  • Reviews, documents, and escalates safety concerns to PV management
  • Excellent Written and Oral communication skills
  • Proficient in standard computer software (Word, Excel and Power point)

Certification

  • CCRP (Certified Clinical Research Professional), SoCRA.
  • Graduate Certificate in Advanced Drug safety and Pharmacovigilance.
  • HIPPA Certified.
  • ICH GCP Training.


Timeline

Senior Pharmacovigilance Specialis

Pfizer
01.2021 - Current

Drug Safety Specialist

Merck
05.2018 - 12.2020

General Physician

Nalluri Multispecalty Hospital
02.2015 - 11.2017

MBBS (Equivalent To US MD) -

Dalian Medical University

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Poornima Gaddipati MD