Roles and Responsibilities :

- Process case reports of adverse events (AEs) and serious adverse events (SAEs) received from various sources, including clinical trial participants, healthcare providers, and spontaneous reporting.
- Conduct thorough reviews of AE/SAE reports to identify potential signals of concern and determine whether they meet regulatory criteria for reporting.
- Collaborate with cross-functional teams to resolve discrepancies in reported data and ensure accurate coding according to industry standards (e.g., MedDRA).
- Develop and maintain documentation of all activities related to pharmacovigilance operations, including case processing workflows, procedures, and training materials.

Job Requirements :

- 2-4 years of experience in drug safety or a related field such as clinical trials or medical affairs.
- Robust understanding of Argus Safety software system; ability to learn new systems quickly (ArisG preferred).
- Proficiency in MedDRA coding system; knowledge of other relevant terminologies like ICD-10-CM/PCS.
- Experience working with literature search tools like PubMed or ClinicalTrials.gov.

📌 Safety Specialist I/ II (Telangana)
🏢 Syneos Health
📍 Telangana