Nikita Naik

Pharmacovigilance Professional with 6+ years of experience in Case Processing and Argus Safety. Currently working as a Trainer, setting up PV cases processing systems .Superb ability to succeed in challenging, high- pressure, performance-driven environment.
 

January 2022 - Current
Cognizant Technology Solutions - Mumbai, India
Trainer

Set up case processing conventions as per client SOP from Case intake till Submission activity
Updating process training related documents as per agreed timeline
Set up of routine follow up and targeted questionnaire activity
Lead the client calls
Creation of Role Description Documents
Responsible for achieving 100% Organizational and Client specific training compliance for entire project
Leading team of 4 people during implementation of new process tool
Responsible for onboarding and offboarding process
Maintaining Training files record
Maintaining Project GTP

October 2019 - December 2021
Cognizant Technology Solutions - Mumbai, India
Data Analyst
Case Processing

Case intake and allocation of cases received from Safety Mailbox, E2B, EMA MLM and client sharepoint. Tracking of pending cases
Book in and Triage of Spontaneous,PMS,Literature,Clinical trial and Regulatory Authority cases
Perform data entry of all the fields including the verbatim. Narrative writing.
Perform Safety case correction activities (irrespective of source, report type and seriousness)
Routine Follow up activity (Generate action item and contact log). Management and tracking of follow up
Unbinding of clinical trial cases (if required)
Literature review
Quality review of cases for completeness and accuracy
Case Submission to Affiliate/Licensing Partner and Health Authorities (EVHUMAN, MHRA, Health Canada). Non-submission of reports from inactive destination
Creation and version control of trackers required for case management
Workflow monitoring to ensure reports submitted within regulatory timeline
Tracking of deletion cases
Raising query on EDC database for CT cases
Maintaining record for access

Reconciliation:

Affiliate , Licensing partner reconciliation and documentation
Reconciliation of non-valid cases (not to be database and rejected cases)
Reconciliation of intake trackers versus Mailbox, E2B and EMA MLM portal,cases received from client share point
Periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies

January 2017 - September 2019
Cognizant Technology Solutions - Mumbai, India
Junior Data Analyst

Case intake and allocation of cases received from Safety Mailbox, E2B and client sharepoint. Tracking of pending cases.
Book in and Triage of Spontaneous,PMS ,Literature,Regulatory Authority and clinical trial cases
Perform data entry of Spontaneous,PMS,Regulatory Authority and clinical trial cases.
Reconciliation of case processing related trackers

December 2015 - December 2016
Cognizant Technology Solutions - Mumbai, India
Trainee Junior Data Analyst

Case intake,allocation and acknowledgement
Legal case processing
Legal case QC

B. Pharmacy with gold medalist