VCLS
Location
Bangalore | India
Job description
· Process safety reports (pre- & post-market) according to SOPs and project/program specific safety plans
· Safety reports triages, evaluation for completeness, accuracy, and regulatory reporting
· Distribute safety reports to appropriate project personnel in the workflow for further processing activities
· Enters data into safety database (ABCube Safety-Easy / Aris Global LSMV)
· Code events, medical history, concomitant medications and tests
· Draft case narratives
· Assesses information to be queried and follow-up until information is obtained and queries are satisfactorily resolved
· Ensure high quality safety reports preparation with minimal comments during quality control
· Perform quality control safety reports prepared by other team members
· Communication with Client or other parties as identified in the project/program for safety report review and validation
· Coordinates with relevant stakeholder reconciliation of safety data
· Participates in project specific teleconferences/meetings as required
· Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements and project/program specific safety plans
· Coach/mentor case management and processing team members
· Ensures all relevant documents files as per SOP or other applicable project/program requirements
· Maintains understanding and compliance with SOPs, regulations, GCP, ICH guidelines, GVP, project/program plans
· Escalate any problem
· Participate in continuous improvement of all Service Unit processes and procedures by identifying and implementing efficiencies in workflow and/or case processing
· Participate in audits/inspections as required
· Assist in database validation through performance of user testing
· Other duties assigned by management
Job tags
Salary
