Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Renuka Boggeti

Summary

Pharmacist with strong experience and technical background, in pharmaceutical medicine and medical device industries (mainly in pharmacovigilance and regulatory reporting), which expands over 12 years in United States and India. Excited to leverage excellent management skills in the field of pharmacovigilance to join CSL as Senior Manager.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Pharmacovigilance Training Manager

Risetrainings
12.2020 - 03.2023
  • Managed and trained over tenteam members on pharmacovigilance operations of post marketing and clinical projects, including reporting of individual case safety reports (ICSR) and aggregate safety reports.
  • Planned and implemented Pharmacovigilance Project startup activities.
  • Prepared and implemented Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEAs). Experienced in preparation of PSMF.
  • Assessed impact, updated project management plans, internal work instructions and trained PV staff as required on updated pharmacovigilance legislations from regulatory intelligence .
  • Assisted in updating standard operating procedures (SOP) in accordance with regulatory updates.
  • Ensured Audit and inspection readiness of projects. Participated in internal and client Audits.
  • Ensured pharmacovigilance processes are in line with regulatory requirements.
  • Planned and executed preparation of periodic reports (PSUR, PADER), Risk management plans (RMPs).
  • Ensured quality is maintained across project. Performed root cause analysis, and planned and unplanned and deviations filing as required. Ensured corrective and preventive actions (CAPA) are taken.
  • Organized meetings regularly with internal and external stakeholders, vendors and staff as required.
  • Routinely checked status, metrics and compliance reports, ensuring KPI's are reached and maintained.
  • Managed MedDRA upgrades in Argus and Arisg databases.
  • Experienced coordinating and working with cross functional teams to update PV systems per updated regulatory authorities' legislations.

Technical Lead and Subject Matter Expert (SME)

IQVIA
06.2014 - 10.2019
  • Played key role as lead to organize team and distribute work diligently day to day to effectively meet quality standards and timely submissions of adverse event reports to regulatory authorities, vendors and other affiliates.
  • Trained new team members on adverse events triage, case booking, ICSR processing, narrative writing, coding using MedDRA and WHODD, query generation and resolution, archiving, regulatory reporting, investigator alert letters, unblinding procedures.
  • Worked in Subject matter expert (SME) role involving responsibilities of knowledge share and guidance with planning and implementation of new strategies, and improvisation of existing workflow plans for safety operations and regulatory teams.
  • Worked on handling teams working in cross functional areas of case processing and regulatory reporting of individual case safety reports (ICSRs) and aggregate reports (PSURs and PADERs) to various regulatory authorities and business partners worldwide.
  • Assisted client with all regulatory requirements of project (eg., Smpc updates, XEVMPD updates, RMPs, product license updates etc.,).
  • Planned, implemented and constantly improvised project plans and strategies to make sure assigned tasks are completed in a timely manner.
  • Performed Key role in ensuring readiness, and experienced in handling Audits and inspections.
  • Ensured safety database is programmed appropriately in a timely manner per regulatory requirements.

Quality Control Specialist

IQVIA
08.2012 - 05.2014
  • Ensured Quality standards are maintained across assigned pharmacovigilance projects.
  • Performed Root cause analysis, and planned and unplanned deviations filing.
  • Processed adverse event reports, product complaints and completed regulatory reporting.
  • Initiated critical follow-up requests via phone, mail or fax as appropriate to ensure completeness of case. Ensure case closure appropriately after sending follow up requests.

Research Associate

Long Island University
10.2010 - 01.2012
  • Assisted principal investigator (PI) with laboratory procedures for a pharmacology project.
  • Assisted PI with research and initiating new pharmacology projects.
  • Assisted professor with teaching activities at pharmacy classes.
  • Routine lab maintenance

Project Intern

GVK Biosciences
11.2007 - 06.2008
  • Worked on QSAR and computational modelling of protein structures.
  • Docking and simulation energy studies of Computational models of drugs onto computational protein structures..

Education

Master of Science - Pharmacology And Toxicology

Long Island University
New York, USA
01.2012

Bachelor of Science - Pharmacy

JNTU
India
04.2007

Skills

  • Management
  • Regulatory Affairs
  • Knowledge of TGA and MEDSAFE guidelines
  • Quality control
  • Project startup
  • Standard operating procedures (SOP) updating
  • Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEAs), PSMF
  • Cross functional team work coordination
  • Audits
  • Inspections
  • PV compliance
  • GCP

Certification

Good clinical Practice (GCP) certified

Regulatory Affairs certified (RAC)

Timeline

Pharmacovigilance Training Manager

Risetrainings
12.2020 - 03.2023

Technical Lead and Subject Matter Expert (SME)

IQVIA
06.2014 - 10.2019

Quality Control Specialist

IQVIA
08.2012 - 05.2014

Research Associate

Long Island University
10.2010 - 01.2012

Project Intern

GVK Biosciences
11.2007 - 06.2008

Master of Science - Pharmacology And Toxicology

Long Island University

Bachelor of Science - Pharmacy

JNTU

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Renuka Boggeti