Summary
Overview
Work History
Education
Skills
Languages
Personal Information
Timeline
Generic

Tejasri P

Chennai

Summary

Dynamic Drug Safety Scientist with a proven track record at Accenture, skilled in regulatory compliance and safety reporting. Expert in MedDRA coding and aggregate report preparation, demonstrating strong problem-solving abilities. Successfully ensured timely submissions to regulatory agencies, enhancing data accuracy and completeness while fostering teamwork across cross-functional teams.

Overview

10
10
years of professional experience

Work History

Drug Safety Scientist

Accenture
Chennai
12.2018 - 03.2025
  • Executed data entry for individual case safety reports into safety database.
  • Reviewed and evaluated adverse event case information to determine necessary actions per internal policies.
  • Coded medical history, events, drugs, procedures, indications, and laboratory tests using appropriate dictionaries.
  • Crafted medically relevant safety narratives for cases while ensuring data accuracy and completeness.
  • Assessed data in safety database to confirm thoroughness and precision.
  • Conducted preparation, review, and analysis of aggregate reports, including PADER, PSUR, PBRER, ACO, and ASR.
  • Generated NDAs, PSURs, CIOMs, and summary tabulations from Argus and Clinevo databases.
  • Analyzed clinical trial and post-marketing surveillance data for serious adverse events (SAEs) and adverse drug reactions (ADRs).
  • Prepared narrative sections detailing individual ADR cases and summarizing various ADRs.
  • Collected safety and efficacy data from clinical trials, preclinical studies, spontaneous reporting systems, and literature.
  • Wrote comprehensive sections on introduction, safety data, conclusions, and recommendations based on clear data findings.
  • Performed medical literature monitoring in PubMed for significant articles relevant to safety.
  • Ensured timely submission of reports to regulatory agencies such as EMA and FDA in compliance with guidelines.
  • Worked closely with safety physicians, signal management teams, clinical research, regulatory affairs, and quality assurance teams to ensure the data was accurately represented.
  • Ensured that the product's safety profile was consistently communicated through updated labeling and product information when necessary.
  • Experienced in the preparation of cover letters, 356H forms.
  • Expert in eCTD compilations and submissions of PADERs through ESG to the US FDA.
  • Knowledge of the Sugam portal for Indian PSUR submissions.
  • Ensure reports are submitted within specified timelines to meet regulatory obligations.

Clinical Data Specialist

Svasth Life Private Limited
Banglore
05.2018 - 12.2018
  • Maintained an internal curated database of laboratory data, including LOINC codes and international standards.
  • Managed regular updates from partner databases while overseeing quality and resolving discrepancies.
  • Ensured accurate storage of lab values with appropriate biological reference ranges for each partner.
  • Supported feasibility assessments by querying study attribute data and reporting findings to project teams.
  • Assisted in publishing internal and external catalogs of aggregated trial data for product offerings.
  • Coordinated with teams to synchronize data definitions and curation activities across analytics products.

Senior Executive

Medi assist Healthcare Private Limited
Bamgalore
12.2016 - 03.2018
  • Developed applications for health checks, consultations, pharmacy orders, and lab investigations.
  • Generated reports from MediBuddy Plus warehouse containing detailed branch and order data.
  • Managed sales functional areas to optimize project outcomes.
  • Utilized Base SAS to import and export raw data to formatted datasets.
  • Employed various SAS procedures to create datasets and summarized reports.

Assistant Professor

seven hills college of pharmacy
Tirupathi
09.2015 - 08.2016
  • Served as Assistant Professor, supervising multiple projects in pharmacotherapeutics.
  • Created lesson plans and developed instructional materials covering required topics and learning objectives.
  • Advised students in personal matters, driving academics, attendance and behaviors.
  • Organized guest lectures from experts in the field of study to supplement course content.
  • Attended faculty meetings and participated in student outcome assessments with departmental members.
  • Collaborated with colleagues on curriculum development initiatives to ensure academic excellence.
  • Advised students on their academic plans, career paths, and personal goals.

Education

Pharm.D - Pharmacy

Andhra University
Bhimavaram
01.2014

Skills

  • Case identification and processing
  • Data entry and management
  • MedDRA coding
  • Regulatory compliance
  • Safety database oversight
  • Follow-up coordination
  • Problem solving and analysis
  • Guideline referral
  • Aggregate report preparation
  • Medical narrative writing
  • Safety reporting
  • Teamwork and collaboration

Languages

  • English
  • Telugu
  • Hindi

Personal Information

  • Date of Birth: 08/31/90
  • Gender: Female
  • Marital Status: Married

Timeline

Drug Safety Scientist

Accenture
12.2018 - 03.2025

Clinical Data Specialist

Svasth Life Private Limited
05.2018 - 12.2018

Senior Executive

Medi assist Healthcare Private Limited
12.2016 - 03.2018

Assistant Professor

seven hills college of pharmacy
09.2015 - 08.2016

Pharm.D - Pharmacy

Andhra University

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Tejasri P