Prajwal Tarale
B.Pharm
Akola,Maharashtra
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
7
7
years of professional experience
2018
2018
years of post-secondary education
3
3
Languages
Work History
Pharmacovigilance Safety Reporting Associate
Icon Plc
10.2022 - Current
- Schedule the report's like CIOMS, MedWatch, E2B(XML), MedWatch 3500A and Quality review for the MDCG form.
- Expedited the Regulatory reporting of processed case via email, Getaway submission, portal submission as per the regulatory timeline.
- Submission of periodic report(PADER, DSUR, Quarterly report, submission of line listing etc.)
- Had a sound knowledge on regulatory intelligence database, and the case scenarios like event seriousness, type of report , mode of submission.
- Preparation of study management plan and maintenance of regulatory requirement on timely manner and provide the training to the peer group members.
- Performed bulk reporting in the safety reporting database and resubmission if any negative acknowledgment received.
- Trained on Global Compliance Tracker, DocuSign 21 CFR Part 11.
- For medical device, submission of CIOMS, MedWatch 3500A, MDCG, to Health Authority, Central Ethics Committee, IRB Investigators and Licensing Partner as per the study contract.
- Maintaining the submission compliance report for assign study to mitigate the quality of submission on time.
- Keep the assign study audit ready with the completion of audit QC checklist and eTMF filling.
- Successfully handled the Client Qualification Audit, Internal Audit,Client Audit for assign Studies.
- Good understanding of unite billing for the in-scop activity.
- Developed and maintained strong relationships with key clients to ensure high levels of satisfaction and won the standalone studies.
Junior Data Analyst
Cognizant
03.2021 - 10.2022
- Schedule the report's like CIOMS, MedWatch, E2B(XML), MedWatch 3500A and Quality review for the MDCG form.
- Expedited the Regulatory reporting of processed case via email, Getaway submission, portal submission as per the regulatory timeline.
- Argus Case finalization
- Knowledge of MEDDRA, WHODD.
- Knowledge on ICH guidelines
- Case processing for the Spontaneous,Post-marketing Surveillance, Literature cases.
- Enhanced data accuracy by meticulously cleaning and organizing datasets for analysis.
Drug Safety Associate
TCS
10.2018 - 03.2021
- Case triage, duplicate search using multiple filters like Name, patient number, event term, any worldwide number, author etc.
- Responsible for ICSR case processing in ARGUS Database.
- Case triage for the ICSR submission.
- Quality Check for case processing.
- Source document retrieval and archiving activity.
- Worked on unblinding and SafeTrack activity.
- Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
Education
B. Phram -
IPER Collage Wardha, Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)
Wardha, IndiaSkills
Case Submission to FDA, EU/EEA
MDR(Medical Device Reporting)
Case Processing
eTMF
ARGUs Case Finalization
Case processing
Quality assurance
Regulatory reporting
Audit preparation
Submission compliance
New hire training
Accomplishments
- Win the project excellence award for completing project with in defined timeline, SME for Global Compliance Tracker, Appreciation latter zero Audit Finding.
- Agile award for study set up in Global Compliance Tracker and preparation of study set-up checklist.
Timeline
Pharmacovigilance Safety Reporting Associate
Icon Plc
10.2022 - Current
Junior Data Analyst
Cognizant
03.2021 - 10.2022
Drug Safety Associate
TCS
10.2018 - 03.2021
B. Phram -
IPER Collage Wardha, Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)