Argus , Aris G
Abhijit Gamare
Regulatory Submission specialist
Navi Mumbai
Summary
Regulatory Submission Specialist with 8 Plus years of experience in Pharmacovigilance on Safety Databases Like Argus and Aris G. I have experience in case processing, Quality review, and Regulatory Submissions.
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
10
10
years of professional experience
33
33
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
Safety Data Analyst (Regulatory Submission Specialist)
Fortrea Scientific Services And Solutions
11.2020 - Current
- As a Regulatory submission specialist, responsible for Manual ICSR Submissions (Gateway and Non Gateway) to Global Health authorities USFDA, MHRA, EMA and Business Partners as per the HA reportability Requirements and criteria.
- Oversees training for new associates in E2B and manual submissions to global health authorities (USFDA, EVHUMAN, MHRA, Health Canada), covering expedited, non-expedited, MOCRA, and dietary supplement cases to USFDA.
- Manages single and bulk ICSR gateway submissions, tracks failed/Negative acknowledgements and manual acceptances, and disseminates daily scenario updates to the team.
- Responsible for Tracking of each reportable ICSR reports (E2B, CIOMS, MedWatch )
- Live tracking of the Due and near Cases and timely checking the reportability of the ICSR reports to each HA and Partner.
- Allocation and tracking of reconciliation of the ICSR reports, to avoid Compliance risk
- Adhere to the Timelines of Partners and reporting criteria as per PVA(SDEA) agreements
- Monitored deliverables for quality and adherence to regulatory reporting timelines
- Respond to requests from regulatory agencies to share information
- Group Mailbox handling with maintaining tracker.
- Worked as Case processor and Quality Reviewer for various case categories on Aris G Database
- Hands on experience Case processing and quality review of Spontaneous, Literature, Study cases received from social media, call center, Mail communications, full text literature articles, courtesy reports, RA cases and licensing partner cases
- Implement consistent, efficient and quality processes to meet timelines and deliverables according to
- Perform any other support activities as assigned tracking various types of information and metrics (Second line review)
- Review of literature articles to identify case safety reports
- Execute drug safety data management processes triage
- Case entry, medical coding, Narrative writing, peer review, case follow-up, report preparation and submission to regulatory authorities
- Provided technical expertise during incident investigations conducted jointly by internal staff members from different functional areas.
- Assisted in the implementation of corrective actions following accidents or near-misses, preventing future occurrences.
- Maintained accurate records of all safety incidents, ensuring timely reporting to relevant stakeholders.
- Act as SME for team Members to resolve submission related Queries and complex issues.
- Giving insights for gateway testing and configuration of company dictionary products.
- Ensured regulatory compliance by keeping up-to-date on industry standards and best practices in safety management.
- Participated in regular team meetings to discuss current projects, evaluate progress made towards established goals, and address any emerging concerns promptly.
Pharmacovigilance Associate
TATA CONSULTANCY SERVICES
07.2017 - 11.2020
- Worked as a source document reviewer and sorting of Documents to Track potential adverse events From all type of Medical documents
- Exposure of Aris-g database and Ag exchange for data entry of new case (DRT,IRT)
- Exposure of Argus safety database
- Worked as Case processor and Quality reviewer for various case categories in E2B RA spontaneous/PMS/ Literature Pharma and vaccine cases
- Case processing in LAM Spontaneous pharma and vaccine case category, Case merging activity from duplicate case to case of record Case processing E2B LP Spontaneous cases
- Performed internal Quality check Activity of E2B RA Cases
- Additional role-Capturing processor level inputs (Data elements R3 /R2) for RPA (Robotic Process automation)
- Duplicate check activity (DCA) and Data Quality review (DQR) of the spontaneous cases
- Worked on UAT testing implemented in Argus database for all workflow cases, Worked with the IT team for add on things to simplify RPA Machine BOT Run (Automation anywhere)
Medical Coder
Gebbs healthcare solutions
11.2015 - 07.2017
- ICD-10 Coding, CPT coding, knowledge about medical Diagnosis, Reports, MDM
- Emergency Department (ED) coding E/M
- Hands on reviewing Electronic Health Records (EHR) reviewing Transcribed and Hand written medical records and upon Medical Decision Making by the physician in the report on the Patient's disease severity and treatment and appending the correct E/M service code, procedural/surgery (CPT) code and ICD code for disease and disorders
- CPC Certified Medical coder from AAPC (Not Active now)
- Reconciliations activity of EHR (Denial reports)
Education
High school or equivalent - SSC
Navi Mumbai Highschool
07.2007 - 06.2008
HSC - HSC (Science)
Other
08.2008 - 06.2010
Bachelor's - Bachelor of Pharmacy
Shri D.D. Vispute College of Pharmacy and research center
08.2010 - 11.2015
MBA - Project Management
Dr D Y Patil Vidyapeeth
04.2001 - 07.2026
Skills
- Case processing, Quality review
- ICSR Gateway, Non Gateway Submissions
- Expertise to train new joiners
- Complex problem solving ability
- Excellent communication skills
Languages
Marathi : Fluent
Hindi : Fluent
English: Fluent
Software
Certification
CPC-P - Certified Professional Coder-Payer
Timeline
Safety Data Analyst (Regulatory Submission Specialist)
Fortrea Scientific Services And Solutions
11.2020 - Current
Pharmacovigilance Associate
TATA CONSULTANCY SERVICES
07.2017 - 11.2020
CPC-P - Certified Professional Coder-Payer
12-2016
Medical Coder
Gebbs healthcare solutions
11.2015 - 07.2017
Bachelor's - Bachelor of Pharmacy
Shri D.D. Vispute College of Pharmacy and research center
08.2010 - 11.2015
HSC - HSC (Science)
Other
08.2008 - 06.2010
High school or equivalent - SSC
Navi Mumbai Highschool
07.2007 - 06.2008
MBA - Project Management
Dr D Y Patil Vidyapeeth
04.2001 - 07.2026
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