Hello,
This is ShivaRaj from The Fountain Group, we are currently seeking a PV Clinical Scientist for a prominent client of ours. This position is located in Fully Remote (PST). Details for the position are as follows:
Summary of Position:
- The PV Clinical Scientist - ICSR Case Management performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety (US Government Client).
- The PV Clinical Scientist - ICSR Case Management performs clinical review of US Government Client cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Manager - ICSR Case Management in all activities.
- All responsibilities are performed under the direction of the PV Clinical Manager - ICSR Case Management.
Key Accountabilities:
- Completes patient safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Standard Operating Procedures(SOPs)
- Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Clients global safety database. Performs seriousness / validity/causality assessments and conducts quality review of all cases (as applicable) based on their medical assessment
- Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
- Responsible for Clinical Review of cases processed in-house and by vendors
- Understands case processing data to evaluate error rates and potential compliance impact
- Responsible for training internal US Government Client and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis
- Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
- Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Scientist - ICSR Case Management/Vendor staff via the communication module
- Accountable for training internal and external staff members on using communication module
- Performs daily reconciliation of outgoing communications