Shreyansh Pateria
Bengaluru
Summary
Dynamic Pharmacovigilance Specialist with extensive experience at Primevigilance, excelling in safety data management and regulatory submissions. Proven ability to enhance team performance through effective training and collaboration. Adept at quality review processes, ensuring compliance and accuracy in clinical trial reporting. Committed to continuous improvement and adaptability in fast-paced environments.
Overview
11
11
years of professional experience
Work History
PV officer
Primevigilance
04.2023 - Current
- Quality review of the clinical trial cases using relevant documents and communication.
- Generating safety queries in the different EDCs (Veeva and Medidata) as needed for medical data assessment.
- Generating different types of aggregate reports via OBIEE for workflow, DSUR and reconciliation.
- Contribute to provide input in the study start up related to safety management plan (SMP) and safety database.
- Working closely with physicians and clients to maintain standardized safety data.
- Prioritizing the cases depends on criticality and coordinating with physicians to close the cases on time.
- Performing monthly SAE reconciliation with clinical database.
- Provide input in setting up automated fields in the safety database like causality and narrative etc.
- Contributing to preparing of SAE form, narrative templates, queries templates during study start up.
- Generating reports for submission required activity.
- Performing submissions to regulatory agencies (USA, EMA, Canada, Australia and MHRA).
- Communicating with vendors for project-related activities.
- Prepare project related quality reports.
- Provide training to the new team members and continuously try to improve team member skills and concepts.
Associate team lead
Tech Mahindra
12.2022 - 03.2023
- Medical devices quality review.
- Device design modifications and create 3D models in solid works.
- Should costing.
- Device design validation and verification of medical devices quality review.
- Device design modifications and create 3D models in solid works.
- Device design validation and verification.
Pharmacovigilance Specialist
Biorasi CRO
09.2021 - 11.2022
- Quality review of SAE cases which are reported during clinical trials in the Argus safety database and discuss the query with the sponsor if any discrepancies in the report.
- Configure new studies in the Argus safety database.
- Perform SAE reconciliation for each subject and maintain spreadsheets.
- Creating narratives for SAE reports and correcting them based on medical monitor feedback.
- Maintain a tracker, such as Coding, SAE, queries, and SAE reconciliation.
- Performing tasks to improve the process.
- SOPs for the safety team are being written.
- Preparing for a safety management plan.
- Perform configuration of different fields of Argus via Argus console.
- Perform configuration and updation of MedDRA and WHO-DD dictionary.
- Medical coding of different terms in different EDC databases (IBM, Medidata and Medrio).
- CAPA analysis of late cases.
- Submission of cases to regulatory agencies.
- Involve in vendor management.
- Review queries in EDC.
- Performing UAT for EDCs.
Quality Review
Cognizant Technology Solutions
01.2019 - 08.2021
- Review cases for errors, missing information, and legibility. Ensures cases are processed per conventions and regulations.
- Conduct Quality Huddles for the team to discuss the ongoing trends in error and cascading the latest process updates to the team.
- Evaluate adverse event reports and assess regulatory status which is seriousness and expectedness/relatedness in order to prioritize workload and ensure timely submission.
- May perform risk and quality function on adverse event reports including manual coding as needed.
- May determine need for and request follow-up using appropriate communication method.
- Provide RCA of case errors.
- Discuss with team main area of lacking understanding.
- Handle weekly client calls and discuss case related queries.
Medical Device Officer
Cognizant Technology Solutions
01.2019 - 08.2021
- Processing a single device and combination device cases in the global Product Technical Complaint Database. (COMET).
- Process cases that are related to handling error, misuse, or force damage, related to the manufacturing process.
- Identify Product technical complaints.
- Identify Product technical complaints which is leading to any serious or non-serious events.
- Identify complaints related to device issues or it’s a handling error.
- Add different types of code in each case depending on the device complaint and investigation of the conclusion.
- Accessing the reportability and incident category of each case depends on the product's technical complaint.
- Process each case within the timeline.
Argus Validation and Testing
Tata Consultancy Services
04.2014 - 01.2019
- Prepare User Requirement Specification (URS) and the Traceability Matrix for different modules of Argus.
- Prepare scenarios for UATs and FTs for testing.
- Writing User Acceptance Test (UATs) Script and System Test Script.
- Execute each test script while doing a dry run.
Quality Reviewer
Tata Consultancy Services
04.2014 - 01.2019
- Check legal cases and maintain quality of legal cases.
- Checking overall completeness and consistency of case against the source document.
- Verify coding and assessment.
- Check the critical fields which affecting the case report for submission.
- Handle weekly client calls and discuss case related queries.
- Taking MOM and Hurdle weekly.
Case Processor
Tata Consultancy Services
04.2014 - 01.2019
- Manage the receipt of adverse event reports from Post Marketing Surveillance Studies and clinical trials.
- Complete triaging of incoming safety reports for initial assessment of validity, seriousness, expectedness, and causality per the FDA regulations, International guidelines/regulations, and Local work instructions.
- Identify and select cases for processing, review case criteria to determine the appropriate workflow, determine appropriate prioritization criteria, and perform late case investigations by noting reasons for any delay.
- Complete case processing of adverse event reports including SUSAR, SAE, and AE in the GSD (ARGUS 8.0) for Initial/Follow-up cases received via source document.
- Ensure correct coding of suspect products in the GSD per coding policies.
- Code concomitant/past medications using WHO-DD.
- Code medical terminologies including Serious/Non-serious AE terms, Medical/Surgical procedures, Therapeutic indications, Lab investigations, and Medical History accurately using MedDRA dictionary.
- Write and update case narratives. Gather information related to the case and process the same.
- Generate standard safety queries during the quality review.
- Responsible for the closing of safety cases as per Client SOPs.
- Support to Generation of different types of reports.
- Perform quality control of ICSRs and prepare them for submissions to the regulatory authorities.
- Ensure all cases that require expedited reporting to the worldwide regulatory agencies are processed appropriately within specified timelines.
- Perform reconciliation of safety data between the global safety and the clinical trial database.
- Attended RCA-CAPA (route cause analysis-corrective action and preventive action) sessions every week.
- Provide mentoring and shadowing to new associates.
Education
Doctor of Pharmacy -
Kakatiya University
Warangal01.2014
Intermediate -
M.P Board
01.2008
Skills
- Ability and eagerness to learn new things
- Ability to work independently
- Ability to work in a team
- Positive thinking
- Adaptability to new environments
- Well oriented with teamwork
- MS Word
- MS Excel
- MS PowerPoint
- Internet applications
- Safety data management
- Clinical trial reporting
- Regulatory submissions
- Quality review processes
- Medical coding
- Pharmacovigilance principles
- Vendor management
- Team training
- Report writing
Accomplishments
- Rewarded as the best quality reviewer.
- Received star performance award.
- Received appreciation reward for good quality.
- Service commitment reward.
Passport Place Of Issue
B-205, kalpataru sunrise kolshet road, Thane, MH, India
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Passport Issue Date
07/13/11
Personal Information
- Passport Number: J6321322
- Passport Expiry Date: 12/07/31
- Father's Name: Shri. Subhash Pateria
- Mother's Name: Smt. Anita Pateria
- Date of Birth: 12/08/89
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
PV officer
Primevigilance
04.2023 - Current
Associate team lead
Tech Mahindra
12.2022 - 03.2023
Pharmacovigilance Specialist
Biorasi CRO
09.2021 - 11.2022
Quality Review
Cognizant Technology Solutions
01.2019 - 08.2021
Medical Device Officer
Cognizant Technology Solutions
01.2019 - 08.2021
Argus Validation and Testing
Tata Consultancy Services
04.2014 - 01.2019
Quality Reviewer
Tata Consultancy Services
04.2014 - 01.2019
Case Processor
Tata Consultancy Services
04.2014 - 01.2019
Doctor of Pharmacy -
Kakatiya University
Intermediate -
M.P Board
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