Arijit Pramanik
Operations Specialist 1 at IQVIA || Trainer || Quality Reviewer || Pharmacovigilance || Drug Safety || Regulatory Submission || PV Agreement || Clinical research || Ex-Cognizant || Personal Finance Enthusiast ||
- Role
- Operations Specialist 1 Regulatory Submissions and Pva at IQVIA
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Arijit Pramanik
Senior Drug Safety associate (8.5 years of work experience in Pharmacovigilance domain) with demonstrated history of working in the CRO, Information technology, skilled in MedDRA coding, Argus Safety, Literature case processing, Regulatory Reporting and Submissions, Safety Data Exchange Agreement (SDEA), GVP, ICH-GCP, experienced working in PMS and CT projects dealing with gastrointestinal, immunological, neurological, hematological products and Covid -19 vaccination. Strong information technology professional with a Bachelor of Pharmacy degree focused on Pharmacovigilance, Clinical research, studied in Guru Nanak Institute of Pharmaceutical Science and Technology, Kolkata, India.Regards,Arijit Pramanik
Experience
Operations Specialist 1 Regulatory Submissions and Pva
May 2023 — Present · Kolkata, IN
Reviewed, assessed, and processed safety data and information across service lines, ensuring compliance with applicable regulations and Standard Operating Procedures (SOPs).2. Handled post-marketed Individual Case Safety Reports (ICSR) regulatory reporting and various regulatory submissions.3. Determined and assessed ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence.4. Checked cross-reports across licenses of pharmaceutical products and submitted regulatory reports related to post-marketing and clinical trial projects.5. Transmitted, approved, and submitted reports according to reporting rules and the Regulatory Intelligence Database for each destination.6. Sent submission emails to Health Authorities (HA) and submitted them based on positive acknowledgment received from HA and Local Qualified Person for Pharmacovigilance (LQPPV).7. Conducted quality reviews to ensure reports for each destination were submitted accurately and on time.
Education
Guru Nanak Institute of Pharmaceutical Science and Technology
Bachelor of Pharmacy - BPharm, Pharmacy
2013 — 2017
Labpur Jadablal High School
Class: Secondary and Higher Secondary
2009 — 2013
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