Nancy Choudhary

Well-established occupational drug safety specialist offering more than 7 years of expertise. Exceptional experience in safety and compliance inspections. Known for excellent management skills and knowledge in Reporting and distribution to Competent Health Authorities.

• Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs)
• Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
• Initiation of ICSRs into the safety database
• Data Entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required
• Trained in MedDRA coding in accordance with MedDRA Term Selection
• Mentoring the new recruits till they are handing the work independently
• Maintaining knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including: ICH guidelines on safety and efficacy FDA guidelines CIOMS New EU PV legislation Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies and responding to clients/customers in a timely manner
• Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Performing distribution and quality check of CIOMS 1 forms/E2B files to stakeholders according to the agreed timelines, distribution list and email templates (as required)
• Performing submission to Competent Authorities and tracking acknowledgement of receipt (as required) and its QC
• EV WEB Trader inbox monitoring
• Uploading and performing quality check for all source documents and relevant mails to the case on ARGUS after reporting and distribution.

• Infections and Infestations
• Immunology/Autoimmune Diseases
• Dermatology
• Cardiovascular
• Metabolic disorders
• Hematology
• Virology
• Rheumatology
• Psychiatric and CNS Disorders

• Post Graduate Teacher of Biology, Arihantas, sector-6, Panchkula, 11/2016 to 03/2017
• Post Graduate Teacher of Biology, Vision Academy, Kangra, 01/2016 to 10/2016

I hereby declare that the   above-furnished particulars are true to the best of my knowledge. If given a chance, I will prove my efficiency, loyalty & willingness to   work in a good environment.

Nancy Choudhary