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Pradeep Krishna Chintapalli

Bis 2019, Global Safety and Pharmacovigilance Assistant, Syneos Health

Fähigkeiten und Kenntnisse

Project Management
MS Office
Team work
Communication skills
Consulting
Risk Assessment and Management
Reliability
English Language
Management
Regulatory Compliance
Science Communication
Public speaking
Interdisciplinary Collaboration
Regulatory Processes
attention to detail
Client Interaction
EDC Systems
CAPA
QA KPIs
REACH
FDA
EMA
Regulatory Intelligence
Document Preparation
Visual Storytelling
Auditing
Policy Development
QMS eDMS GMP GDP
Clinical Trial Applications (CTA)
INDs (Investigational New Drugs)
NDA (New Drug Application)
Quality and Environmental Management System
ISO 9001
ISO 14001
Medical Device Regulation (MDR)
IFRA
EFFA

Werdegang

Berufserfahrung von Pradeep Krishna Chintapalli

  • 1 Jahr, Okt. 2022 - Sep. 2023

    Science Photographer

    SystemLink Research Group

    Captured terrestrial predator populations, notably spiders, to study their behavior and ecological importance. Coordinated multiple project activities including on-site photo sessions and facilitated collaboration among research teams.

  • 6 Monate, Mai 2021 - Okt. 2021

    Intern

    Centre for the Advanced Study of Collective Behavior

    Project Title: Quantification of decisionmaking in larval Zebrafish in response to minimal concentrations of agrochemicals. Description: Researched agrochemical impact on larval zebrafish, employing behavioral tracking to quantify effects and contribute to environmental protection. Ensured scientific rigor and collaboration in a multidisciplinary team.

  • 1 Jahr und 5 Monate, Nov. 2017 - März 2019

    Global Safety and Pharmacovigilance Assistant

    Syneos Health

    Performed comprehensive case assessments using ARGUS database to ensure regulatory compliance. Utilized MedDRA and WHO DD for accurate adverse event classification and crafted detailed SAE narratives. Delivered precise client responses, enhancing satisfaction and trust in products/services. Assisted in submissions to National Competent Authorities (NCA), and conducted regulatory intelligence.

Ausbildung von Pradeep Krishna Chintapalli

  • Bis heute 5 Jahre und 8 Monate, seit Okt. 2019

    Environmental Pollution Management (Ecotoxicology)

    University of Kaiserslautern- Landau (RPTU)

    Specialized coursework in risk assessment and management, including exposure and effect modeling techniques. Extensive study of chemical toxicology and ecotoxicology principles. Emphasis on chemical fate and transport in the environment.

  • 4 Jahre, Juni 2013 - Mai 2017

    Pharmacy

    SIMS College of Pharmacy

    Studied regulatory submissions for new drugs, explored clinical trial regulatory aspects in drug development, and learned FDA and EMA pharmaceutical regulations.

Sprachen

  • Englisch

    Fließend

  • Telugu

    Muttersprache

  • Deutsch

    Grundlagen

  • Hindi

    Fließend

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