Argus (821)
Open To Work
Dheeraj Jindal
Quality Reviewer
Gurgaon
Summary
Experienced with pharmacovigilance processes and adverse event reporting, ensuring regulatory compliance and patient safety. Utilizes strong analytical skills and detailed-oriented approach to identify and mitigate potential drug risks effectively. Knowledge of industry regulations and risk management practices, contributing to safer pharmaceutical outcomes.
Overview
3
3
Languages
3
3
Certifications
8
8
years of professional experience
Work History
Quality Reviewer
Wipro Ltd.
11.2018 - 12.2025
- Analyze and handle adverse event reports following applicable regulations, standard operating procedures, and project mandates within designated timelines, while meeting quality expectations.
- Proficiency in case processing, peer reviewing spontaneous case literature, CIOMS reports, regulatory authority cases, product quality complaints, and vaccine case management.
- Handle all incoming cases to maintain compliance with timelines.
- Deliver results on assigned cases with consistent proficiency.
- Coordinated follow-ups with reporters of ICSRs by crafting queries and sending requests to ensure timely resolution.
- Maintain strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
- Engage with internal teams to acquire critical information needed for daily operations.
- Coordinate follow-ups with reporters of ICSRs, including crafting queries, and sending requests.
- Review source documents, coding standards, and ad-hoc inquiries with the client through email.
- Performed additional drug safety tasks to support overall safety management efforts.
- Drafted and distributed follow-up letters for NDA reporting, PQC filling, refund filing, DCA, and STQ.
- Compiling data daily to maintain a track record.
- Engaged with internal teams to gather critical information essential for daily operations, enhancing workflow efficiency.
- Conduct additional drug safety tasks assigned.
- Direct the case to the subsequent workflow state as necessary in the safety database.
- Participate in training sessions and cultivate abilities consistently.
- Participated in team meetings, trainings, and workshops to support continuous improvement initiatives aimed at enhancing reviewer skills and processes.
- Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
- Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes.
Clinical Research Intern
Medanta Institute of Clinical Research
06.2018 - 07.2018
- Conducted screening of study participants to assess eligibility for clinical trials.
- Managed informed consent process by explaining study details to participants to ensure understanding.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Familiarity with FDA regulations and IRB requirements.
- Use of electronic data capture systems.
- Assisted in the evaluation of investigational products' safety and efficacy, contributing to successful clinical trials.
- Performed accurate statistical analyses on collected data sets using various software programs to evaluate trends and outcomes in clinical trials.
- Assisted in the evaluation of investigational products'' safety and efficacy, contributing to successful clinical trials.
- Developed strong relationships with patients through empathetic listening skills, enabling better understanding of their experiences during the trial process.
- Participated in ongoing professional development opportunities such as attending workshops and training sessions related to clinical research best practices.
Education
Post Graduate Diploma in Clinical Research And Pha - Clinical Research
Institute of Clinical Research India At Medanta Hospital (ICRI-MIER)
Gurugram, India 04.2001 -
Bachelor of Pharmacy - Pharmacy
Adesh Institute of Pharmacy And Biomedical Science, Adesh University
Bathinda, India 04.2001 -
Skills
ICH guidelines
Regulatory compliance
Medical terminology
Database maintenance
Attention to detail
Adaptability and flexibility
Software
Certification
Good Clinical Practice by NIDA Clinical Trial Network
Interests
Reading Books, Sports, Reading Articles, Workouts
Timeline
Quality Reviewer
Wipro Ltd.
11.2018 - 12.2025
Clinical Research Intern
Medanta Institute of Clinical Research
06.2018 - 07.2018
Post Graduate Diploma in Clinical Research And Pha - Clinical Research
Institute of Clinical Research India At Medanta Hospital (ICRI-MIER)
04.2001 -
Bachelor of Pharmacy - Pharmacy
Adesh Institute of Pharmacy And Biomedical Science, Adesh University
04.2001 -
Declaration
I hereby declare that above furnished Information is true and correct to best of my Knowledge and Belief. Date: Signature: Dheeraj Jindal