4 viewsTalent
Sushanthi M. — Mid-Level Pharmacovigilance Drug Safety Associate from India

Sushanthi M.

Mid-Level Pharmacovigilance Drug Safety Associate

India 1-2 years
Open to offersNew to Platform
Languages
EnglishHindiTelugu
Video Introduction
No video introduction yet
The candidate has not added a video.
Contact information and social networks are private. Connect to unlock.
Hidden

About

Sushanthi M. is a dedicated and detail-oriented Biotechnology professional based in Hyderabad, Telangana, India, with an M.Sc. in Biotechnology. She has significant experience in the healthcare and pharmacovigilance industries. Her expertise includes medical documentation, medical transcription, and pharmacovigilance operations, with a focus on drug safety compliance and regulatory standards. As a Drug Safety Associate and Quality Controller at Vigilare Biopharma, she was responsible for processing and reviewing Individual Case Safety Reports, performing quality checks on adverse event reports, and ensuring regulatory compliance with MedDRA coding and safety case assessments. Additionally, Sushanthi contributed to process improvements that enhanced case review efficiency. Her previous role as a Medical Transcriptionist at Inventurus involved transcribing and editing physician dictations, ensuring accuracy and maintaining confidentiality while managing high-volume assignments. Sushanthi holds certifications in Pharmacovigilance, Clinical Research, and Medical Transcription, and is well-versed in using pharmacovigilance databases and quality review processes.

Experience

  • Drug Safety Associate / Quality Controller

    Vigilare Biopharma · 2023 — 2025
    Reviewed and processed Individual Case Safety Reports (ICSRs) in compliance with pharmacovigilance regulations. Performed quality evaluations on adverse event reports to ensure they met completeness and regulatory standards. Conducted medical and data quality assessments before documentation submission. Verified the precision of coding utilizing MedDRA terminology. Assisted in case reconciliation tasks and database upkeep. Ensured adherence to Standard Operating Procedures (SOPs), global regulations, and client-specific guidelines. Worked collaboratively with cross-functional teams to address discrepancies and enhance case quality. Maintained productivity while upholding quality metrics under strict deadlines.
  • Medical Transcriptionist

    Inventurus · 2016 — 2018
    Transcribed clinical documents including physician dictations, clinical notes, and discharge summaries. Ensured precise documentation of medical records, applying relevant medical terminology. Upheld patient confidentiality following healthcare regulations. Edited and proofread reports to guarantee grammatical, medical, and formatting correctness. Coordinated with healthcare professionals to clarify ambiguous dictations as necessary. Handled a substantial volume of transcription tasks, consistently adhering to quality standards.

Skills & Expertise

Education

  • Master of Science in Biotechnology
    Osmania university · — — 2016
  • Bachelor of Science
    Vasundara women’s Degree Collage OU affiliated · — — 2012

Interested in this professional?

Sign in as an employer to save this profile or invite Sushanthi M. to a job.

Sign in as an employer