Company name – BIOCLINICA
Location – Mysore
Position – Sr. Drug Safety Associate ( PHARMACOVIGILANCE)
Essential Duties And Responsibilities
As Quality Check Reviewer
Review data entered in safety database for completeness and accuracy.
Provide quality feedback to team resources
Track and maintain quality metrics
As Case Processor
Responsible for data entry of Individual case safety reports into the safety database.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
Process all incoming cases in order to meet timelines.
Full data entry including medical coding and safety
narrative. As Medical Coder
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
As Narrative Writer
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
Following up with sites regarding outstanding queries.
Follow up on reconciliation of discrepancies.
Follow departmental AE workflow procedures.
Closure and deletion of cases.
Mentor and guide the activities of the Dug Safety
Associate. High level of proficiency al all workflow tasks.
Perform any other drug safety related activities as assigned.
Specialized Knowledge And Skills
Basic competence with medical and therapeutic terminology.
Ability to work independently but guided by documented procedures, with appropriate support.
Able to work effectively as part of a team.
Understanding of patient safety regulatory obligations.