Hire Talented Drug Safety Associate

Clinical Scientific Expert-II

Prakash Kumar is a Clinical Research and Pharmacovigilance professional with 13+ years of experience in clinical data review, safety surveillance, protocol and ICF development, MedDRA coding, and medical writing. He has extensive expertise across clinical trial operations, regulatory compliance (ICH-GCP, FDA, EMA, 21 CFR Part 11), and safety data review. Prakash collaborates with cross-functional global study teams to support protocol development, CSR writing, SAE/ICSR handling, and e-narrative preparation. Known for driving process improvement, ensuring audit-ready documentation, and mentoring new team members, He consistently delivers high-quality clinical and safety deliverables across multiple therapeutic areas.

Senior Pharmacovigilance Associate

Devansh Desai is a Pharmacovigilance and Clinical Research professional with over 12 years of experience in drug safety operations, case processing, aggregate reporting, and clinical trial coordination. He has expertise in SAE/AE case handling, MedDRA coding, literature surveillance, and preparation of regulatory submissions including PSURs, PADERs, PBRERs, and RMPs. Devansh has supported end-to-end clinical trial activities—ethics submissions, informed consent, data entry, and subject communication—ensuring adherence to ICH-GCP and regulatory requirements. Known for process ownership, documentation excellence, training delivery, and cross-functional collaboration, he consistently ensures high-quality, audit-ready deliverables in safety and clinical environments.

Drug Safety / Pharmacovigilance professional

Ishan Gupta is a Drug Safety / Pharmacovigilance professional with 9 years of experience managing end-to-end ICSR case processing, regulatory compliance, and inspection readiness in global pharmaceutical environments. He has extensive expertise in Argus Safety, MedDRA/WHODrug coding, literature surveillance, and quality documentation. Known for leading teams, mentoring associates, handling escalations, and optimizing PV workflows, Ishan ensures timely and audit-ready safety deliverables aligned with EMA, FDA, MHRA, and GVP regulations. He consistently drives quality, collaboration, and operational efficiency across pharmacovigilance functions.

Pharmacovigilance and Drug Safety professional

Shiv Kulkarni is a Pharmacovigilance and Drug Safety professional with over 10 years of experience supporting global clinical trials and PV operations within a leading pharmaceutical client (Roche). He specializes in ICSR processing, regulatory narrative writing, MedDRA coding, eCRF safety review, and safety data reconciliation. Shiv is highly skilled in safety systems including ARISg, LifeSphere Multivigilance (LSMV), Clinical Veeva Vault, and Smart Query tools. Known for maintaining 100% regulatory compliance, leading UAT activities, and managing multiple high-priority projects independently. Recognized with multiple performance awards for quality, efficiency, and process innovation.

Drug Safety Senior Scientist

Rachit Sharma is a Senior Drug Safety / Pharmacovigilance professional with over 13 years of experience in global case processing, regulatory submissions, SAE management, narrative writing, and quality control. He has extensive hands-on expertise using Argus and Arisg databases, SAE reconciliation, MedDRA coding, and e2b transmission workflows. Rachit consistently delivers high-quality, audit-ready safety deliverables, while ensuring compliance with regulatory timelines and global pharmacovigilance requirements. Known for her analytical approach, leadership capability, and strong documentation skills, He excels in handling complex safety cases, training team members, and driving process improvements.