Patient Safety Associate
Enter reports of drug side-effects from post-marketed or clinical study sources to the safety database. Handle non-serious and serious cases according to regulatory requirements, process instructions, and standard operational procedures. Resolve queries related to pharmacovigilance activities and individual case reports.
- Ensure completion of basic training and team-specific training (on category A (and B) cases) in case handling.
- Begin and complete the process for competency sign-off on category A (and B) cases.
- Before sign, off, perform the initial phase of the case handling process, including the triage activity and uploading adverse event source documents into the safety database.
- After the sign, off, enter initial and follow-up information for adverse event case reports of category A (and B) cases into the safety database, using data interpretation, coding, and writing skills in accordance with the effective process instructions, SOPs, and OPIs to ensure data consistency and compliance to high data quality standards.
- Ensure compliance to the client and TCS procedural documents and policies.
- Perform all activities within the required timeframes to ensure regulatory compliance.
- Collaborate with Medical Advisors with regards to adverse event capturing, seriousness, or company causality assessment.
- Raise and manage safety queries within the required timeframe.
- Support a performance-driven culture.