Job Description. Book in and Triaging of ICSRs. Perform data Entry of ICSRs in Pharmacovigilance database. Entering source data in the database, Coding, Narrative(s) writing, and Generate Follow-up letters. Generation of regulatory/partner submission reports and submission of cases. Send follow-up/administrative queries. Review of literature articles and assessment for identifying valid ICSRs. Compliance to project guidelines. Execution of Compan...
Job Description. Supervise or perform the periodic reconciliation of safety report information between the drug safety database and local PV representatives (PQC, CRO, Data Management, LSM, etc.). Management and oversight of PV vendor(s) regarding intake and reconciliation activities. Support the management and oversight of Case Management Mailboxes and other sources of intake for ICSR processing. Support PV management in the oversight of vendor-...
