Lavanya Durga Koppisetti
Hyderabad
Summary
Proven expertise in regulatory compliance and quality assurance, honed at IQVIA and other leading institutions. Excelled in streamlining document QC processes and enhancing pharmacovigilance operations, showcasing strong decision-making and effective organization. Achieved significant improvements in TMF accuracy and inspection readiness, underpinned by proficiency in Microsoft Office and exceptional communication skills.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Sr. Records Management Associate (eTMF Specialist)
IQVIA RDS India Pvt Ltd
09.2022 - 09.2024
- Ensure that project timelines are met, and facilitate the orderly transfer, imaging, scanning, retention, and disposition of various project-related and business records.
- Managed and maintained the Trial Master File (TMF) to ensure compliance with ICH-GCP, FDA, EMA, and sponsor requirements.
- Performed quality control (QC) checks to ensure TMF completeness, accuracy, and inspection readiness.
- Reviewed, indexed, and classified essential clinical trial documents within the TMF reference model.
- Worked with electronic TMF (eTMF) systems such as Veeva Vault and Subway for document management.
- Ensured proper archival and retrieval of TMF documents at trial closeout, as per regulatory guidelines.
- Mentor and train newcomers on the team.
Associate - Pharmacovigilance Officer - II
Indegene (Health minds consulting pvt ltd)
10.2021 - 06.2022
- Processed Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing surveillance, in compliance with global pharmacovigilance regulations (FDA, EMA, MHRA, ICH-GCP).
- Performed case triage, data entry, and narrative writing in safety databases such as Argus, ARISg, or Veeva Vault Safety.
- Assessed adverse event (AE) seriousness, causality, and expectedness based on company core safety information (CCSI), and regulatory guidelines.
- Reviewed and ensured the quality and completeness of case reports before submission to health authorities and partners.
- Collaborated with cross-functional teams, including medical reviewers, regulatory affairs, and clinical teams, to ensure compliance and data accuracy.
- Ensured compliance with safety regulations, and provided feedback for random quality checks.
Drug Safety Associate
IQVIA RDS India Pvt Ltd
12.2020 - 09.2021
- Processed Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing surveillance, in compliance with global pharmacovigilance regulations (FDA, EMA, MHRA, ICH-GCP).
- Performed case triage, data entry, and narrative writing in safety databases such as Argus, ARISg, or Veeva Vault Safety.
- Provided feedback for quality check errors, and ensured timely completion of assigned training.
- Reviewed and submitted safety case reports for regulatory compliance.
Clinical Research Coordinator
LV Prasad Eye Institute
01.2019 - 11.2020
- Coordinated clinical trials, screened and enrolled study subjects, and maintained site master files.
- Performed study procedures and assessments per protocol, and resolved data discrepancies.
- Assisted in reporting adverse events and ensured regulatory compliance for safety-related documents.
- Conducted clinical data review per patient, and updated the principal investigator.
- Obtained informed consents and managed site feasibility assessments.
- Coordinated shipments of investigational products and biological samples.
- Managed data entry into E-CRFs and resolved queries to generate authentic data.
Education
M.Pharmacy - Pharma Management and Drug Regulatory Affairs
Scient Institute of Pharmacy
Hyderabad01.2016
B.Pharmacy -
Mallareddy Institute of Pharmaceutical Sciences
Hyderabad01.2014
Intermediate - M.P.C
Narayana Junior College
Hyderabad01.2010
S.S.C - X grade
Little Scholars' Talent School
Hyderabad01.2008
Skills
- Data collection and analysis
- Regulatory compliance
- Corrective action implementation
- Quality assurance expertise
- Quality management systems
- Documentation review
- Proficiency in Microsoft Office (Excel, Word, and PowerPoint)
- Effective organization and time management skills
- Clear and concise verbal and written communication abilities
- Ability to work independently
- Capable of multitasking
- Prioritizing tasks
- Meeting timelines effectively
- Decision-making capacity
Certification
- Online self-directed Diabetic Retinopathy Grading course, Has successfully completed e-learning training course on grading diabetic retinopathy and passed the competency-based examination conducted by The University of Melbourne.
- Good Clinical Practice and Research Ethics, CT QUEST, 2019
- Registered as Pharmacist with Telangana state pharmacy council.
Languages known
- English, Hindi and Telugu.
Personal Information
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above information is true to the best of my knowledge.
Timeline
Sr. Records Management Associate (eTMF Specialist)
IQVIA RDS India Pvt Ltd
09.2022 - 09.2024
Associate - Pharmacovigilance Officer - II
Indegene (Health minds consulting pvt ltd)
10.2021 - 06.2022
Drug Safety Associate
IQVIA RDS India Pvt Ltd
12.2020 - 09.2021
Clinical Research Coordinator
LV Prasad Eye Institute
01.2019 - 11.2020
M.Pharmacy - Pharma Management and Drug Regulatory Affairs
Scient Institute of Pharmacy
B.Pharmacy -
Mallareddy Institute of Pharmaceutical Sciences
Intermediate - M.P.C
Narayana Junior College
S.S.C - X grade
Little Scholars' Talent School
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