Safety Specialist I/ II

Job description

Roles and Responsibilities : • Process case reports of adverse events (AEs) and serious adverse events (SAEs) from clinical trials, literature, and other sources using Argus Safety software. • Conduct thorough reviews of AE/SAE reports to identify potential signals and trends, ensuring compliance with regulatory requirements. • Collaborate with cross-functional teams to resolve issues related to case processing, including data discrepancies and queries. • Develop and maintain documentation for pharmacovigilance activities, such as protocols, procedures, and reports. Job Requirements : • 2-7 years' experience in pharmacovigilance or a related field (e.g., clinical trials). • Strong understanding of Argus Safety software and its applications in drug safety surveillance. • Experience working with MedDRA coding system for reporting adverse events. • Bachelor's degree in Life Sciences or a related field; Master's degree preferred.