Senior Pharmacovigilance Scientist - ProPharma Group formerly known as I Safety Systems Pvt., Ltd. - Hyderabad, India
(2021-10)
- Single point of Contact to manager for handling of few clients which included monitoring of volumes in respective workflow steps, providing quality check and case processing allocation to the team and successfully monitoring of cases as per the regulatory timelines.
- Responsible for conducting weekly quality meetings for the team.
- Client notifications and sharing review reports to the clients based on the due dates
- Maintaining of respective trackers required for the process and client delivery.
- Responsible for making outbound email and fax follow-ups to the reporters and health care professionals
- Responsible for quality check of coding all medical history, events, drugs/procedures/indication and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD)
- Responsible for checking the completeness and accuracy of the data entered in the various fields including narrative, in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs) of all types of ICSR's (Spontaneous, Solicited, Literature) using Arisg database and ARGUS database.
- Ensures that the expectedness, causality assessment as well as seriousness criteria are accurate for the events, causality of events and narrative writing.
- Triage of inbound validity as applicable.
- Performing the ICSR Quality check by marking errors in the quality trackers, filling case tracking sheets, regular quality sessions to case processing team and conduct training to team.
- Regular interaction with client to provide input or receive feedback on findings.
- To prepare and ensure compliance, quality, and adequate deliverables within timeframes to manager.
- Attending internal, drug safety and project-specific training sessions.
- Peer reviews of cases for quality, consistency, and accuracy.
- Perform Health Care Professional (HCP) review (as required).
- Case processing of all types of ICSR's (Spontaneous, Solicited, study, regulatory authority and Literature) using Argus safety database.
- Intake, triage and data entry of all adverse events in the designated territory.
Pharmacovigilance Intern - I Safety Systems Pvt., Ltd. - Hyderabad, India
(2021-05 - 2021-10)
3 months pharmacovigilance internship
