Description

In this role, you will be the key Clinical Safety contact for European Clinical Trials, managing adverse events and ensuring compliance with regulatory requirements. You will collaborate with study committees and mentor junior specialists.

Requirements

• •Bachelor's Degree in related field
• •Strong medical background, cardiology experience, and interest in clinical trial safety
• •Experience in medical device, healthcare, or related environment
• •Business level English (written and spoken)
• •Proven expertise in MS Office Suite
• •Excellent written and verbal communication skills
• •Demonstrated problem-solving and critical thinking skills
• •Knowledge of Edwards policies and quality compliance
• •Proficient knowledge of medical terms and human anatomy
• •Full knowledge of Medical Device Reporting regulations
• •Good knowledge of Good Documentation Practices (GDP)
• •Ability to manage confidential information with discretion
• •Attention to detail
• •Ability to interact professionally with all organizational levels
• •Ability to manage competing priorities in a fast paced environment
• •Ability to work in a team environment
• •Ability to interact with senior personnel on significant matters
• •Adhere to all company rules and requirements

Tasks

• •Track and process complex adverse device events from clinical trial sites
• •Collect source documents for key adverse events from clinical trial sites
• •Determine regulatory reporting requirements based on event criteria and causality
• •Interact with study committees for safety data collection and reconciliation
• •Prepare safety event reports for clinical, regulatory, and complaint handling submissions
• •Ensure compliance with worldwide reporting requirements, including expedited case reports
• •Understand corporate and global regulations, guidelines, and writing practices
• •Coach and mentor junior clinical safety specialists
• •Handle and review adverse events according to SOP and regulatory requirements
• •Identify problems and lead projects to improve processes and procedures

Tools & Technologies

Benefits