Ruchit Lakhanpal

Study Configuration in Argus database/Console): Highly proficient in configuring new studies and safety workflows in Oracle Argus Safety, including product license mapping, E2B routing, and rule configuration tailored to regulatory needs

Regulatory Document Review & Protocol Assessment: Demonstrated expertise in the critical review of clinical trial, Spontaneous, Non-Interventional study, Manged Access Programe and Litertaure protocols, informed consent forms (ICFs), and safety-related documents to ensure alignment with global regulatory requirements (EMA, FDA, MHRA)

Regulatory Writing & Study Documentation: Skilled in authoring and maintaining study-specific guidance documents, product reference documents (SmPC, USPI, CDS), and contributing to Investigational Medicinal Product Dossiers (IMPD) and Investigator’s Brochure (IB)

End-to-End Case Processing: Strong command over complete ICSR lifecycle management for various case types—Clinical Trial (CT), Post-Marketing Surveillance (PMS), Spontaneous, Literature, and Non-Interventional Studies—including intake, triage, data entry, medical coding (MedDRA/WHO-DD), narrative writing and expedited reporting

Labeling & Causality Assessment: Advanced knowledge of global product labeling sources (CDS, IB, SmPC, USPI) for expectedness evaluation and causality determination using tools like WHO-UMC and Naranjo algorithms

GVP, ICH & Regulatory Intelligence: Solid working knowledge of GVP Modules I–XVI, ICH E2E, E6(R2), and 21 CFR Part 11, with ability to interpret evolving regulatory guidance and incorporate into operational SOPs and case management processes

Compliance & Audit Readiness: Proven ability to support internal and external audits/inspections (EMA, FDA, TGA, BfArM), implement CAPAs, and maintain documentation to support audit-readiness and inspection preparedness

Root Cause Analysis (RCA) & CAPA Ownership: Competent in conducting RCA for process deviations, drafting CAPA plans, and tracking corrective actions to resolution in line with quality standards and regulatory commitments

Cross-functional Collaboration: Experience working with global safety, clinical, regulatory, and medical affairs teams to align on timelines, safety deliverables, and regulatory strategy

Mailbox Management & Safety Inbox Oversight: Accountable for monitoring and triaging safety mailboxes, ensuring timely intake of safety data, follow-ups, and data reconciliation across stakeholders

Client & Health Authority Interaction: Engaged in direct communication with clients, Heath Athourities and regulatory agencies to clarify safety requirements, submission queries, and compliance documentation, fostering transparent and proactive relationship management