Abhinav Bawiskar

Pharmacovigilance & Drug Safety Specialist with 10+ years of experience in case processing, triage, adverse event reporting, regulatory compliance, and quality control. Expertise in Argus, ArisG and Veeva. Strong leadership and training abilities with a focus on process optimization and regulatory adherence.

Operation Specialist 1 - IQVIA Healthcare - Thane

(2019-02)

• Triage team workflow management.
• Triage of various cases including solicited, spontaneous, E2B, Canada vigilance, TGA and literature by doing duplicate search, case validity assessment and seriousness assessment.
• Perform follow-up activities in case of missing data and train team members for new updates.
• Identify product compliant (PQC) and product security complaints, collecting necessary information for AE compliant reporting.
• Acted as the primary receiver for all AE reporting by monitoring the safety mailboxes.
• Download of source documents from the Canda vigilance and TGA portals.
• Daily plan check, Inventory management, managed timely processing of safety data and by overseeing departmental workload, prioritizing critical workloads, prioritizing critical cases, query resolution and managed team of 15 associates.
• Trained over 10 associates on various case types for various drug safety requirements.
• Present weekly and monthly quality reports and compliance data for late cases with analysis of root cause analysis and potential CAPA.
• Error trend analysis and conducting training for same.
• Performed daily reconciliation of the source documents which is received in mails boxes from the vendors and set up archival of files.
• Perform late case investigations and propose corrective and preventive actions.
• Deletion tracking.
• Review and quality check of data (Argus) entered by the peer group.
• Provide feedback to the DSA's and analyze quality trends in the group.

Drug Safety Associate (DSA) - Cognizant Technology Solutions - Mumbai

(2015-08 - 2019-02)

Data Entry for Spontaneous, Clinical trials, Litigation and Literature cases. (Cognizant)

• Prioritization of cases according to client due date and ensure completion of data entry within given timeline.
• Processed over 5000 the safety reports in the databases (ArisG), assessed regulatory status which is seriousness and expectedness, relatedness to prioritize workload.
• Responsible for accurate data entry of relevant information in accordance with client SOPs and recent updates.
• Assessment of seriousness of cases and able to identify and code perfect adverse event from source document.
• Communication with client persons in case of any difficulties or queries while processing the cases. Query for follow up information and review responses to queries when received and update in client database.
• Coordination of internal teams to obtain the necessary information for day-to-day operations and attend training sessions.
• Review and quality check the data entered by the peer group.
• Reviewed over 2000 the safety reports in the databases (ArisG).
• Provide feedback to the DSA's and analyze quality trends in the group.
• Responsibility for completion of day-to-day work and quality review process flows.
• 100% quality review of complete data entry, narrative writing and documents that the quality check was performed.
• Maintain necessary peer client communication related to case processing.
• Communicate with the team leader in case of any issues which requires client intervention.
• To perform internal QC of Clinical trials cases and to give feedback to case receiving team, data entry/quality control team and medical reviewer team. Reviewed over 9000 the safety reports in the databases (ArisG).
• To maintain data of regulatory and monitoring fields as per client requirement.
• To generate data of errors this is helpful for training team to conduct training sessions.
• Weekly and monthly meeting with client for the discussion of trend of errors.
• Sampling of cases by doing Randomization and allocation of cases.
• To handle rebuttals with trainers for further discussions on errors.
• To generate various data like Customer pulse (weekly quality) and important calculations regarding quality for the higher management.
• To conduct trainings, surprise tests and spot checks

Master of Pharmacy - Pharmacology - Smt.

Kishoritai Bhoyar

College of Pharmacy, R.T.M.

Nagpur

University (2014)

Bachelor of Pharmacy - Smt.

Kishoritai Bhoyar

College of Pharmacy, R.T.M.

Nagpur

University (2010)

Post Graduate Diploma in Business Administration - Marketing Mgmt - Symbiosis Centre for Distance Learning, Pune (2014)