SME-Pharmacovigilance at Cognizant Technology Solution (2021-08 – Present)
- Evaluate 100% of the cases for accuracy, consistancy and completeness in the safety database against the source document.
- Knowledge of safety data in the database, coding relevant medical terminology, performing quality control and ensure case reporting.
- Review, assess, process and report the adverse event reports according to application regulations, guidelines, SOPs and project requirements within the specified timelines by meeting the quality standards and also assessment of case reports for seriousness, case validation, causality and expectedness.
- Writing narrative based on source documents to represent a case synopsis of the adverse event in a chronological order and also ensure that data entry errors are corrected prior to routing the cases to the next workflow in the ARGUS.
- Generate follow-up letters as needed and ensure all follow up activities have been completed. Routing the case to the appropriate workflow in the global safety database.
Senior Executive at Wipro Technologies (2019-04 – 2021-08)
- Mentored 10-12 mentee from each batch and provided one-on-one feedback to mentee, offering advice and support tailored to their individual needs and goals.
- Offered solutions and strategies for overcoming challenges and obstacles that mentees may encountered in their personal or professional lives.
- I was responsible for duplicate search, follow-up case process, suspect drug coding using CDD and WHODD, event coding using Meddra, seriousness assessment, communicate with clients and multiple vendors to resolve queries, notify PQC to the respective bodies.
- My job role was to complete day-to-day work and quality review of case within the agreed service levels (SLAs) and also 100% quality review of all the assigned cases.
- Updation of defects in the QC form and maintaining the data as per the client specific SOPs and guidelines as applicable & Co-ordinating internal teams to obtain necessary information required for day-to-day operations.
Junior Data Analyst at Cognizant Technology Solution (2016-11 – 2019-03)
Joined as a case processor. My role was ICSR processing, where I was responsible for reviewing and assessing source documents, filling the data in Arisg or Argus database.
- Event Meddra coding, Suspect and concomitant drug coding via CDD or WHODD. Narrative writing and follow up notification set.
- Also Notify partner or other company as per convention. 100%quality along with that mentoring freshers and juniors.
- Promoted to QR, and responsible for reviewing products, services, and processes to ensure they meet quality standards and specifications.
- Maintain detailed records of quality review processes, findings, and corrective actions.
Project Associate at Datacore India Pvt. Ltd. (2015-10 – 2016-11)
- Assigning codes to medical procedures and diagnoses.
- Abstracting patient encounters, including diagnostic and procedural information, significant reportable elements and complications.
- Researching and analyzing data needs for reimbursement.
- Ensuring codes are assigned correctly and sequenced properly.
