Major purpose of the Job: • Literature Screening activity and its management. • Coordination, updation and tracking with CRO for clinical trials data and collection of SAEs received from clinical trials. • Coordination, updation, and tracking with post-marketing safety (PMS) study team for collection of SAEs and AEs. • Responsible for Quality Control Check of ICSRs in safety database with the objective of achieving in high level of regulatory compliance. • Submission of ICSRs to ROW regulatory authorities. • Responsible for Quality Control check of calls and voice mail recording of inquiries (PI, PQC, AE, MI, and General Inquiries) via MICC. Responsibilities: 1. Compliance: • CATS (compliance assessment and tracking system) management. • Maintenance of CAT tracker, Literature tracker, Medical Query Tracker, Quality Control tracker, and SAE tracker. 2. Quality & Compliance Governance: • Revision/Review of quality system-related Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure that there are clear written procedures in place describing the pharmacovigilance system. • Management of ad-hoc work/responsibilities as allocated by Head of Pharmacovigilance or designee. • Participating in any internal audits or external inspections on CPL Global pharmacovigilance functions 3. Signal Management & Risk Evaluation: • Drafting of Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER), Risk Management Plan (RMPs), and Signal Detection Reports as required.
