- Argus Safety
- Drug Safety / Pharmacovigilance
- ICSR (Individual Case Safety Report) Processing
Key Responsibilities
- Perform case selection and allocation as per client SOP and WIs.
- Conduct quality review of valid and invalid cases within defined SLAs.
- Document cases in SMOCQA tool.
- Analyze and review refuted errors.
- Attend internal, client, and vendor oversight meetings.
- Participate in audits as Subject Matter Expert (SME) for Quality Review processes.
- Perform additional tasks assigned by the supervisor.
Required Experience
- 2-6 years of experience in Pharmacovigilance/Drug Safety.
- Hands-on experience in Argus Safety database.
- Strong knowledge of ICSR processing and case quality review.
- Valuable understanding of pharmacovigilance regulations and SOPs.
- Excellent communication and stakeholder management skills.