プロフィール詳細

プロジェクトを作成

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Dr. Mangesh N.に依頼

Germany

Pharmacovigilance and Medical Monitoring (PVP) with 15+ years of experience in clinical trail I -IV phases of lifecycle

プロフィール概要

Strategic Pharmacovigilance & Medical Safety Expert (DVM, PhD, sMBA) Motivated Specialist with 15+ years of experience in international human and animal drug safety. Expert in navigating complex global regulations (ICH-GCP, GVP, AMG, VICH) and the full lifecycle of PV operations, from Triage and MedDRA coding to the assembly of high-level aggregate reports (DSUR, PSUR, PBRER). PhD and Postdoctoral research focused on adverse drug reactions, providing a unique forensic capability to investigate idiosyncratic side effects. Proven track record in Quality Assurance (SOPs, audits, inspections) and regulatory submissions.

専門分野

• ★ Veterinary Medicine
• ★ Clinical Trials
• ★ Pharmacovigilance/Drug Safety Monitoring

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Gray Literature Search

Consulting Scientific and Technical Consulting

Product Development Formulation

職務経験

Pharmacovigilance Physician

Freelancer

8月 2007 - 現在

学歴

PhD

SZIE

9月 2015 - 1月 2018

認定資格

• 認定資格の詳細は未入力です。