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 transparent 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.

📌 Executive Bhat
🏢 Cadila Pharmaceuticals
📍 Bhat