Apprentice Drug Safety

Roles & Responsibilities
• Perform data entry of safety data into adverse event tracking systems
• Write patient safety narratives and accurately code adverse events using MedDRA and WHODD (for marketed products, if applicable)
• Assist in listedness assessment against appropriate product labels
• Support causality assessment in collaboration with medical reviewers
• Generate queries and collect missing or discrepant safety information
• Assist in submission of expedited SAE/SUSAR reports to clients, regulatory authorities, ethics committees, investigators, vendors, and project teams within agreed timelines
• Support preparation, review, and approval of Periodic Safety Reports (PSRs) for investigational products/devices as per applicable regulations
• Ensure compliance with company and sponsor SOPs and regulatory guidelines

Qualification
• Master's degree in Pharmacy
• Doctor's degree in Pharmacy
• Master’s degree in Life Sciences
• Educated to at least GCSE level or equivalent (as applicable)

Experience
• 0–1 year of experience in Drug Safety / Pharmacovigilance
• Exposure to clinical trials preferred
• Academic or project experience in safety data handling will be an advantage

Skills
• Knowledge of MedDRA and WHODD coding
• Understanding of ICH guidelines and pharmacovigilance processes
• Ability to handle safety databases and documentation
• Strong analytical and attention-to-detail skills
• Good communication and stakeholder coordination abilities
• Ability to manage timelines and work in a team environment

About the Organization
Fortrea is a global contract research organization (CRO) providing clinical development and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies, supporting drug safety and regulatory compliance worldwide.