プロフィール詳細

プロジェクトを作成

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Anuradha T.に依頼

India

Pharmacovigilance Quality & Compliance Consultant | Ex-Parexel |11+ years |RCA/CAPA |Trainer| SOP development |Audits

プロフィール概要

I help pharmaceutical and biotech companies fix pharmacovigilance compliance gaps and become inspection-ready especially when facing audit pressure, reporting delays, or complex deviation challenges. With over 11 years of experience in PV Quality & Compliance at Parexel, I have supported global organizations including Johnson & Johnson, Kenvue, Norgine in managing high-risk compliance scenarios and strengthening regulatory performance across global markets. My expertise lies in solving critical pharmacovigilance challenges such as: ✔ Root Cause Analysis (RCA) and CAPA strategy for major deviations ✔ Late ICSR backlog remediation and submission risk mitigation ✔ PV audit and inspection readiness (FDA / EMA) ✔ QMS gap assessments, SOP & PVA optimization, and process improvement ✔ Cross-Functional Team Mentoring & Training I specialize in translating complex compliance issues into clear, structured, and sustainable solutions, helping organizations reduce regulatory risk, improve submission timelines, and confidently navigate inspections. Over the years, I have built a strong reputation for: • Driving audit readiness initiatives • Delivering actionable compliance insights through metrics and trend analysis • Strengthening PV quality systems aligned with global regulatory expectations • Collaborating effectively with cross-functional and global teams If your organization is facing reporting delays, compliance risks, or upcoming inspections, I’d be glad to connect and explore how I can support your team.

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Skills Training
• ★ Employee Training
• ☆ Medical Writing

サービス

• Consulting
• Data & AI

Consulting Healthcare Consulting

Data & AI Data Visualization, Data Cleaning, Data Processing, Data Insights

職務経験

Senior Patient safety specialist

Parexel International

9月 2015 - 4月 2026

Senior Patient Safety Specialist

PAREXEL International (India)

9月 2015 - 4月 2026

学歴

Master in Pharmacy

Central University of Punjab

7月 2013 - 8月 2015

Masters in Pharmacy (Medicinal Chemistry)

Central University of Punjab

7月 2013 - 8月 2015

認定資格

• EEA Qualified Person for Pharmacovigilance (QPPV) Training

  Learning and Development

  9月 2025 - 現在

• How To Respond to an Audit Report

  Learning and Development

  9月 2025 - 現在

• Quality and Compliance Oversight Plan

  Learning and Development

  3月 2021 - 現在

• Quality Issue Management - Corrective and Preventive Action

  Learning and Development

  3月 2020 - 現在

• Root Cause Analysis (CAPA process) Training

  Learning and Development

  2月 2020 - 現在

• Training and Mentoring

  Learning and Development

  2月 2017 - 現在

出版物

JOURNAL ARTICLE

Anuradha Thakur, Kamalpreet Kaur, Praveen Sharma, Ramit Singla, Sandeep Singh, Vikas Jaitak, et al. (2021). Synthesis, In vitro, and Docking Analysis of C-3 Substituted Coumarin Analogues as Anticancer Agents . Current Computer-Aided Drug Design.

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