Apprentice Drug Safety

Roles & Responsibilities
• Perform data entry of safety data into adverse event tracking systems
• Write patient narratives and accurately code adverse events using MedDRA and WHODD (for marketed products, if applicable)
• Assist in listedness assessment against appropriate product labels (for marketed products, if applicable)
• Support causality assessment activities under supervision
• Generate queries and collect missing or discrepant information in consultation with medical staff, if required
• Assist in submission of expedited SAE/SUSAR reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and internal project personnel within agreed timelines
• Support preparation, review, and approval of Periodic Safety Reports (PSRs) for investigational products/devices in accordance with applicable regulations and guidelines

Qualification
• Educated to at least GCSE level or equivalent
• Master’s degree in Life Science

Experience
• 0 to 1 year of experience in Drug Safety
• Strong exposure to Clinical Trials preferred

Skills
• Knowledge of adverse event reporting and safety databases
• Understanding of MedDRA and WHODD coding
• Ability to manage multiple tasks in a structured environment
• Strong collaboration skills with internal and external stakeholders
• Attention to detail and regulatory compliance mindset

About The Company
Fortrea is a global contract research organization (CRO) providing clinical development and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies. The organization supports drug safety, regulatory compliance, and clinical trial operations worldwide, operating in alignment with global standards and sponsor requirements.