Safety Specialist I/ II

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.