Highlights:Accomplished Clinical Safety Manager with 10+ years of experience in pharmacovigilance, clinical trial management, and regulatory compliance. Proven expertise in optimizing safety workflows, leading global Phase III trials across 25+ countries, and ensuring adherence to ICH GCP and global pharmacovigilance regulations. Skilled in Argus Safety, MedDRA, Power BI, and Tableau. Adept at strategic planning, cross-functional collaboration, and mentoring high performing teams.

Skills:Drug Safety, Safety Databases: Argus, Veeva, Coding & Standards: MedDRA, WHO-DD, Data Analysis & Visualization: Power BI, Tableau,, EDC Systems: RAVE, DataLabs, Advanced proficiency in Excel, Word, Powerpoint

Certification:AZ-104 Microsoft Azure Administrator (2023) Fundamentals of GCP (2023) Certified Clinical Research Associate (2015)

Clinical Safety Manager 07/2021 - current
BioNTech SE, Mainz, Rhineland-Palatinate Germany
Industry: Pharma
Clinical Safety Managment of Clinical and Post-marketing IMPs
• Led safety operations for global Phase III trials across 25+ countries, ensuring compliance with ICH-GCP and regulatory standards. • Reduced case processing timelines through workflow optimization and MedDRA coding oversight. • Authored trial-specific plans, including Safety Management Plans and risk management charters, ensuring alignment with regulatory requirements. • Conducted signal detection activities, including literature searches and database analyses, to support benefit-risk assessments. • Trained and mentored in-house staff and clinical trial teams, fostering a culture of learning and empowerment.--
Senior Drug Safety Associate 08/2015 - 06/2021
PRA Health Sciences GmbH, Mannheim, Germany
Industry: Pharma
Drug Safety Management - processing and reporting of safety events in Clinical Trials and postmarketing arena
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UNICAF University 10/2023 - current
Lusaka, , Zambia
Degree: Doctoral Degree
Major:Public Health
Online PhD studies in Public Health

Ambe-Noel Ngwa Resume Pharmacovigilance