Mukesh Kumar

Manager Pharmacovigilance @Awinsa Life Sciences

Noida, IN

Oversaw quality control of ICSRs, meticulously reviewing MedDRA coding and narratives to ensure the integrity and precision ofsafety reports for both post-marketing surveillance and clinical trial contexts.Managed pharmacovigilance (PV) process compliance, adhering rigorously to regulatory requirements laid out in ICH guidelines forsafety and efficacy and FDA CFRs, besides conforming to the stipulations of GVP Modules.Spearheaded the creation and assessment of periodic safety summary reports and played a key role in the drafting and critical reviewof the Pharmacovigilance System Master File (PSMF).Query management and client correspondence to resolve issues related to the processing of ICSRs in accordance with clients’policies.Drafting and review of clinical study report (CSR).Directed a team by strategically allocating workload to enhance operational efficiency, thus ensuring the consistent and punctualdelivery of services to clients.Delivered expert training to the team on AWINSA’s and specific client SOPs, conventions, and guidelines, promoting a culture ofexcellence and continuous improvement.Drafting, reviewing and updating technical documents outlining responsibilities of all the applicable stake holders.Testing and validating the configurations in the ARGUS safety database.Supporting the physicians in signal management activities.Monthly compliance data compilation and presentation.

Kingston University

Master of Science (MSc)

Delhi Institute Of Pharmaceutical Sciences and Research

Bachelor of Pharmacy (B.Pharm.)