Ajay Kumar

About Ajay Kumar

Pharmacovigilance professional with 5+ years of end-to-end experience in global drug safety, including ICSR processing (Clinical Trials, SUSARs, PMS, Spontaneous, Literature), case quality review, and regulatory submissions across US, EU & APAC regions. Skilled in aggregate reporting activities including DSURs, PADERs, PBRERs/PSURs and signal detection. Proficient in ARISg, ARGUS, Mosaic PV, Veeva Vault Safety, and coding with MedDRA & WHO-DD. Working knowledge of basic SAS and SQL for safety data extraction and trend analysis. Recognized for high compliance, training new joiners, and delivering audit-ready documentation in sponsor and CRO settings.

Experience

1. Senior Safety & Pv Specialist

   Syneos Health

   Oct 2024 — Present · Gurugram, IN

   Pharmacovigilance expert with over 5 years of progressive experience in global drug safety operations. Proven leadership in ICSR management, aggregate reporting, signal detection, and team training. Recognized for process excellence, regulatory compliance, and client-focused delivery in high-pressure, global environments.Advanced ICSR Lifecycle Management:Lead processing of Individual Case Safety Reports (ICSRs) from Clinical Trials (Phase I–IV), SUSARs, Spontaneous, Literature, Post-Marketing, and Legal sources.Ensure quality, consistency, and compliance across triage, data entry, coding, narrative writing & submission.Regulatory Submissions & Compliance:Ensure timely submission of expedited and periodic reports (CIOMS, E2B XMLs) in accordance with global regulatory standards: FDA, EMA, MHRA, PMDA.Maintain alignment with ICH E2B(R3), GVP Modules, ICH-GCP & sponsor SOPs.Aggregate Safety Reporting (Periodic Reports):Contribute to the preparation and review of DSURs, PBRERs/PSURs, and PADERs, ensuring accurate case inclusion, data validation & timeline compliance.Signal Detection & Risk Management:Support signal detection activities including case trend analysis, frequency review, and documentation of emerging safety concerns.Case Quality Review & SOP Adherence:Perform first and second-level QC of cases to ensure medical accuracy and data integrity.Champion adherence to SOPs and regulatory guidelines, with a focus on inspection readiness.Training, Mentorship, Subject Matter Expert (SME) in ICSR processing and safety database use:Deliver training sessions, support onboarding of new team members, and lead knowledge transfer sessions across global teams.Cross-functional & Global Collaboration:Work closely with regulatory affairs, clinical operations, medical reviewers, and global client safety teams for timely resolution of safety-related queries.Contribute to process improvement, client engagement, and system optimization initiatives.

Education

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  Bachelor of Pharmacy - BPharm, Pharmacy

• Kendriya Vidyalaya

  High school

• Kendriya Vidyalaya

  Higher secondary