- OVERALL PURPOSE OF JOB
Reviewing medical literature, safety data, draw conclusions from safety reports, clinical reports, proficiency in medicalreport writing and safety standards. Clinical Review of all cases - serious and non-serious safety reports
Responsibilities/ Authorities :
Reviews and verifies appropriate selection of adverse events from source documents, appropriate MedDRA code for each adverse event and accuracy of label assessments for each adverse event. Adjust to changing regulatory environment.
Provides a medical evaluation comment for all serious spontaneous, unlisted adverse events and serious related events from studies and solicited adverse events
Provides assessment(s) for study cases and solicited reports.
Reviews the source document to assure relevant information pertaining to the case is appropriately entered.
Verifies consistency between source documents and narrative summary.
Attaches/ reviews all letters and queries for appropriateness and completeness.
Oversees all the team resources in the work.
Provide technical and/ or configuration, best practices to team resources as required
Oversee execution of Quality Control and discrepancy management for outputs
Assist in training for new resources and as a part of continuous improvement
Assist in the development of documentation such as work instructions or task checklists for readiness activities as required
Interact pro-actively within and across areas to facilitate system and process improvement
Lead and participate in team meetings (Onshore and Offshore)
Ensure compliance with client and company policies
Own assist and comply to all SLAs (Cycle time and quality
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