Summary
Overview
Work History
Education
Skills
Certification
Languages
Accomplishments
Timeline
Generic
Prasanth Gogineni

Prasanth Gogineni

Berlin

Summary

Detail-oriented and experienced Drug Safety Associate with over 3 years in pharmacovigilance and clinical safety operations. Adept in end-to-end ICSR processing (spontaneous, solicited, clinical trial, literature), MedDRA and WHO-DD coding, regulatory submissions (E2B R2/R3), and medical writing. Strong knowledge of global PV regulations (FDA, EMA, ICH-E2A), safety database systems (Oracle Argus, ArisG, Veeva Vault), and compliance with SOPs, CAPAs, and audit readiness protocols.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Drug Safety Associate

Clinical Maple Tree Analytics Pvt Ltd
03.2022 - 03.2025

· Processed ICSRs across various sources: spontaneous reports, clinical trials, solicited sources, and literature.

· Conducted comprehensive triage, data entry, coding (MedDRA & WHO-DD), narrative writing, and case submissions.

· Ensured compliance with global regulatory requirements (FDA, EMA, ICH, CIOMS) and submission timelines.

· Utilized Argus Safety, ArisG, and Veeva Vault for accurate E2B (R2/R3) submissions.

· Authored clear and concise narratives aligned with medical standards.

· Performed thorough case quality control (QC) and participated in audit preparation.

· Assisted in safety database configuration and initial signal detection activities.

· Supported creation of aggregate reports (PSURs, DSURs, PADERs).

· Maintained effective communication with cross-functional stakeholders including medical reviewers and QA teams.


Education

Masters - Global Health Care Management

Coventry University
04.2021

Bachelors - Doctor Of Pharmacy

Sjm College of Pharmacy
06.2018

Skills

    ICSR Case Processing (Spontaneous, Solicited, Clinical Trial, Literature)

    MedDRA & WHO-DD Coding

    Regulatory Submissions (E2B R2/R3 – FDA, EMA, CIOMS)

    Narrative Writing & Medical Documentation

    Signal Detection & Aggregate Reporting (PSURs, DSURs, PADERs)

    Argus Safety, ArisG, Veeva Vault

    SOP Compliance, CAPA Handling, Audit Readiness

    Cross-functional Collaboration (Medical, QA)

Certification

  • 2025-04 German Level (a2 Goethe Certified )
  • 2015-07 Workshop on Research Methodology, Biostatistics, and Ethics
  • 2015-12 67Th Indian Pharmaceutical Congress

Languages

German Level (A2 Goethe Certified)).
English fluent

Accomplishments

    · Reduced ICSR processing errors by 15% through effective implementation of quality control measures.

    · Achieved 99% accuracy in MedDRA and WHO-DD coding across all case types.

    · Contributed to aggregate safety reports (PSURs, DSURs, PADERs) and signal detection using Veeva Vault.

    · Played a key role in regulatory inspection preparedness, resulting in zero non-compliance issues.

Timeline

Drug Safety Associate

Clinical Maple Tree Analytics Pvt Ltd
03.2022 - 03.2025

Bachelors - Doctor Of Pharmacy

Sjm College of Pharmacy

Masters - Global Health Care Management

Coventry University

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