CV / English / Clinical Safety Scientist

Personal Information

• Name: Stella Marquez
• Address: 5472 Cortez Circle, Innovation City, BioTech Valley, 90210
• Phone: (555) 123-4567
• Email: [email protected]

Brief

A dedicated Clinical Safety Scientist with over 7 years of experience in conducting comprehensive safety assessments, clinical trial reviews, and risk management in the pharmaceutical industry. Proven expertise in analyzing clinical trial data, reporting adverse events, and ensuring compliance with global regulatory standards. Adept at working within cross-functional teams to advance patient safety and drug efficacy.

Core Competencies

• Clinical Trial Safety Assessment
• Adverse Event Reporting Systems (AERS)
• Risk Management Plans
• Regulatory Compliance
• Database Management
• Signal Detection and Analysis
• Cross-functional Team Collaboration
• Strong Analytical Skills

Technologies and Certifications

• Proficient in ARGUS, ARISg, and MedDRA
• Certified Clinical Research Professional (CCRP)
• Advanced knowledge of MS Office Suite and statistical analysis software
• Training in Good Clinical Practice (GCP) and pharmacovigilance (PV) principles

Professional Experience

Clinical Safety Scientist, BioTech Pharma Inc., Innovation City June 2018 – Present - Led the safety assessment of over 10 major clinical trials, consistently identifying and mitigating risks. - Developed and implemented a novel method for enhanced adverse event reporting, improving reporting efficiency by 30%. - Collaborated with regulatory affairs to ensure compliance with FDA, EMA, and other global health authority regulations.

Associate Clinical Safety Scientist, Health Solutions Ltd., BioTech Valley January 2016 – May 2018 - Supported senior scientists in the safety monitoring of clinical trials, including data collection and analysis. - Contributed to the development of risk management plans and safety reports. - Assisted in the conducting of regular safety review meetings and the preparation of regulatory submission documents.

Education and Training

Master of Science in Pharmacology, University of Health Sciences, BioTech Valley 2014 – 2016

Bachelor of Science in Biological Sciences, Innovation University, Innovation City 2010 – 2014

Referees

Dr. Michael Riviera Director of Clinical Research BioTech Pharma Inc. Email: [email protected] Phone: (555) 987-6543

Ms. Lora Kensley Senior Clinical Safety Manager Health Solutions Ltd. Email: [email protected] Phone: (555) 234-5678