Experience

Covance

• United States
• Research Services
• 700 & Above Employee

• Lead

  • Nov 2022 - Present

  Site Selection lead II, involves oversight of the entire feasibility/site selection process Site Selection lead II, involves oversight of the entire feasibility/site selection process



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Site Support Analyst

  • Mar 2022 - Oct 2022

• Feasibility support assistant

  • Feb 2015 - Mar 2022

  >To maintain the ICON Investigator database>Data entry registration forms, recruitment data, site and country information as required>Review profiles of updated Investigator records>Search for duplicate records >Data entry and checking of questionnaires for missing data.

• Site Support Analyst

  • Feb 2015 - Mar 2022



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Operations Specialist / Senior Drug Safety Associate

  • Apr 2011 - Dec 2012

  • Was a part of the pilot-core team/ SME (subject matter expertise) for a project involving transition of anti-TNF drug, which involved training sessions from the clients, attending various ORT calls in order to facilitate a smooth transition of the project and understanding the new process/ drug specific conventions.• Quality review of the spontaneous cases (serious and non-serious cases), literature cases, recall cases prior to reporting to the regulatory abiding to the SOP’s and timelines.• Managing the team at the time of crisis, by prioritizing the cases and ensure reporting the cases within timelines.• Pulling out reports for daily work allocation to the team members and monitoring the team productivity on daily basis and coordinating with the managers regarding the team output.• Providing training and mentoring the new hires on case processing.• Subject matter expert of anti-TNF drugs and psychotic drugs. Handling new products/drugs by getting trained by the clients and processing the cases. Training the team on the case processing functions and monitoring the quality, interacting with the clients and answering the related queries.• Monitoring the performance and quality of the team and enabling in achieving the quality target as required by the client.• Subject matter expert and point of contact for preliminary assessment of cases that deviate from the process and escalation of the same to the respective client POC’s.• Involves processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet.• Performing consistency checks of the cases for labeling and other parameters.• Processing line listing of different drugs.

• Senior Drug Safety Associate

  • Apr 2010 - Apr 2011

  • Part of a small global team working towards entering the cases in to the database• Involves important decision making for entering the case in to the data base. Searching forduplicate reports previously reported in the data base and registry the case.• Processing the patient data, assessing the seriousness, monitoring the adverse events,coding the events with the help of MEDRA, labeling the events according to the CompanyCore Data Sheet.• Quality check of the spontaneous cases, clinical trial cases, literature cases, legal cases,recall cases prior to reporting to the regulatory sticking to the SOP’s and timelines.• Was a part of 2 special projects (involving Oncology drugs), in support with the clients.

• Pharmacovigilance Specialist / Drug Safety Associate

  • Sep 2008 - Apr 2010

  • A post marketing surveillance involving meticulous processing of patient reports received from the client’s trial sites and marketed by abiding the standard operating procedures (SOP). • Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.• Involves important decision making for entering the case in to the data base, processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet.• Have been a part of the core team that is involved in the initial assessment of the cases before being entered in the database. • Trained on Literature surveys, reviewing, assessing and decision making for reportability by looking for positive attribution in the literature article.