Arijit Chowdhury
Kolkata
Summary
Seeking a challenging career in an organization that promotes growth, stability and opportunity for
advancement in the field of Formulation Regulatory Affairs, IPQA,Documentation QA or Development Quality Assurance
Overview
8
8
years of professional experience
Work History
Senior Safety Associate
4C Pharma Solution
Hyderabad
10.2024 - 12.2024
- Company Overview: Drug Safety Services, Hyderabad
- Perform Review, evaluation, classification, reportability criteria and follow up activities on medical devices product complaints
- Summarize investigation results based on technical analysis
- Receive complaint information, evaluate and database it
- Perform Failure coding, Event coding, Hazard coding activities
- Follow up to gather more information, and handling product returns activities
- Any other responsibilities including cross-functional assignments delegated by the organization to fulfil business needs
- Drug Safety Services, Hyderabad
Junior Data Analyst
Cognizant Technology Solutions
Kolkata
03.2023 - 04.2024
- Company Overview: Kolkata
- Data entry of ICSRs (including spontaneous reports, PMS cases, License partner cases, social media cases etc.), evaluates ICSR data for completeness, accuracy, and regulatory report ability
- Codes events, medical history, concomitant medications and laboratory tests
- Compiles complete narrative summaries and raise proper query action item for missing information which boost the medical aspects to complete the case
- Prioritizing the cases based on Regulatory due timelines, SLA and seriousness
- Resolving problems associated with case processing and sharing case processing quality feedback with team
- Performed triage, completeness, legibility and validity of incoming adverse event case reports (Serious and Non-serious events) originated from clinical and post marketing studies
- Extensive knowledge in case timelines, assessing seriousness criteria and event assessment
- Maintaining professional working relationships with all project team members, internal and external
- Involved in all project related updates discussion through daily and weekly huddle
- Kolkata
Senior Drug safety associate
Wipro limited
Kolkata
03.2021 - 02.2023
- Company Overview: Kolkata
- Processing of serious adverse events (SAE's) from Spontaneous & Non Interventional Studies receiving from global sources in various documents
- Complete processing & validity of incoming adverse event case reports (Serious and Non-serious events) originated from post marketing studies
- AE/SAE management, MedDRA/WHO-DD coding, labelling assessment of AE/SAE, Narrative writing
- Data entry of ICSRs, following the criteria set by the client and in-depth knowledge in Processing case types of solicited, unsolicited, E2B, Device, Vaccine and Merge cases
- Experienced in working at different workflow levels like Case Processing and Quality control
- Extensive knowledge in case timelines, assessing seriousness criteria and event assessment
- Resolving problems associated with case processing and sharing case processing quality feedback with team
- Coding of other company drugs using WHO DD
- Generating HCP and Non-HCP letters, for doing follow-up activities for an ICSR
- Meet productivity and quality target
- Kolkata
Quality Assurance Chemist
Eskag Pharma Private Limited
Haridwar
03.2017 - 10.2019
- Company Overview: Haridwar
- Worked as In process Quality Assurance (Q.A.) chemist of oral solid dosage form (Hormonal) in ESKAG PHARMA PVT
- LTD
- Haridwar
Education
Master of Pharmacy - Pharmaceutics
Maulana Abul Kalam Azad University of Technology
West Bengal12.2021
Bachelor of Pharmacy -
Maulana Abul Kalam Azad University of Technology
West Bengal12.2017
Skills
- Good Pharmacovigilance Practice (GVP)
- Communication
- Team player
- Case processing
- Quality review
- ARGUS
- Intake (PVI) Drug Safety Database
- ICSR
- MedDRA
- WHO Drug Dictionary Coding
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Languages
- English
- Hindi
- Bengali
Disclaimer
I hereby declare that the information provided here is best of my knowledge and belief.
Personal Information
- Date of Birth: 02/26/96
- Nationality: Indian
- Marital Status: Un-married
Place
Kolkata, India
Timeline
Senior Safety Associate
4C Pharma Solution
10.2024 - 12.2024
Junior Data Analyst
Cognizant Technology Solutions
03.2023 - 04.2024
Senior Drug safety associate
Wipro limited
03.2021 - 02.2023
Quality Assurance Chemist
Eskag Pharma Private Limited
03.2017 - 10.2019
Master of Pharmacy - Pharmaceutics
Maulana Abul Kalam Azad University of Technology
Bachelor of Pharmacy -
Maulana Abul Kalam Azad University of Technology