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