Safety Specialist I/ II
Syneos Health · Gurugram, Haryana, India - Hyderabad, Telangana, India
Syneos Health · Gurugram, Haryana, India - Hyderabad, Telangana, India
**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.