Rahul Kesari, PharmD, RPh, MSRA

Supervised daily operations and a team of security personnel to ensure campus safety. Developed procedures, managed schedules, and coordinated incident response. Collaborated with departments to support events, policy enforcement, and emergency preparedness.

•Created and archived submission records, ensuring proper metadata capture, organization, and accessibility, following company standards for document classification and lifecycle management. •Learned end-to-end application lifecycle management, which includes Joins associated with the specific application, how to navigate joins within the application, and linking submissions, correspondence, and commitments. •Verified and quality checked regulatory data to ensure accuracy and completeness across RIM systems •Identified and classified 2,665 clinical documents based on the Type; Subtype (e.g., Study Protocol, IB, CRF); Classification (e.g., Redline version, memo, Full Protocol or Protocol Amendment, Adverse Events Listing). •Collected around 5000 documents from different sources to one location to support checksum verification to identify duplication, RIM vs Document to be migrated in RIM to avoid duplication upload. •Reviewed and corrected 1172 HA correspondence records (CRPDs) as per the naming convention to ensure consistency across all CRPDs, making them easier to track, search, and reference. •Verified key metadata such as method of communication, attachments, received/issue dates, and product information. This ensured that all records were accurate, complete, and compliant with internal and regulatory standards. •Reviewed 118 Correspondence and associated response submissions to collect the RFI received date and response submitted date to identify the total duration of the RFI to the Response. •Created and maintained training resources, such as reference guides, work instructions, and FAQs, to enhance RIMS usability. •Collaborated with the Global Regulatory Operations (GRO) and GSO team on cross-functional initiatives and ad hoc tasks.

Experienced professional with 5 years of Regulatory Affairs expertise in the Pharmaceutical sector. Proficient in managing submissions for variations, post-approval changes, life cycle management, and national to MRP changes. Skilled in utilizing various tools including Salesforce, RIMS, Veeva Vault, Insight for Publisher (IP), eCTDXPress, Lorenz and EURS validator, Extedo, SmartDesk, and ISI toolbox.

• Managed triage and data entry of Individual Case Safety Reports (ICSRs) in the safety database, ensuring compliance with regulatory timelines. • Drafted safety narratives, ensuring thorough and accurate adverse event reporting. • Performed administrative duties in line with company policies and procedures.

• Conducted daily audits across various wards (Medicinal, Gynecologic, Pediatric, ICU, etc.) in a 150-bed super-specialty hospital. • Identified and resolved 100+ drug-drug interactions, side effects, and adverse drug reactions (ADRs), improving patient safety and medication effectiveness. • Provided patient counseling, treatment chart reviews, and prescription drug analysis to enhance understanding and adherence to treatment plans. • Assisted in patient recruitment, data collection, and administering pre-test/post-test knowledge assessments. • Collaborated with healthcare professionals to educate patients on disease management, prevention, and treatment adherence, delivering educational sessions that increased patient awareness by 40%.