Sandeep Dubey
Douglas, Cork
Summary
I have overall 6 years of experience working in Pharmaceutical industry including 2 years of Laboratory experienced worked in GMP regulated lab environment and 4.1 Years of working experience in Pharmacovigilance regulatory domain within Clinical Research Organization Covance for external clients like J&J & Novartis. I have previously worked in a dynamic environment where being a team player was the most effective way to get the work done, but also working alone helped me to gain focus. Gained valuable experience in Quality Control,LIMS, SAP Pharmacovigilance, Team management. Some of the qualities which define me as a person are, patience, hardworking,a sound mindset of willingness to adjust to new changes and environment.
Overview
6
6
years of professional experience
Work History
Quality Control Analyst 02 (Sample Management)
Janssen Sciences Ireland Cork
Cork , Ireland
2023 - 2023.12
- Experience working in GMP regulated environment following FDA/EMEA guidelines
- Maintained policy, procedures, work instructions, and projects for quality and continuous improvement agendas.
- Ali-quoting bulk samples Suit 1/2/3 and various other ad-hoc samples
- Temptale download, review, RM update on BSI database
- Created test plans for incoming raw materials prior to use in production lines.
- Conducted audits of internal systems, processes, products and services in order to assess their effectiveness.
- Critical test result data entry and date review on lab access database, LIMS
- Performed root cause analysis on non-conforming materials to identify problems and corrective action plans.
- Participated in regular meetings with management team members discussing progress towards achieving company objectives related to product excellence.
- Trained other analysts to perform laboratory procedures and assays.
Patient Scheduling Representative (Remote)
Relatecare Healthcare
Waterford , Ireland
2021.11 - 2022.09
- Performing non-clinical screening to ensure patients are seen by the right physician.
- l Performing data entry of patient’s information into various systems like Epic database.
- Utilized document management system to organize company files, keeping up-to-date and easily accessible data.
- Resolved customer complaints in a professional manner while remaining empathetic to their concerns.
- Consistently met daily performance goals set by management team members.
- Answered phone calls and directed them to appropriate personnel
Sr. Drug Safety Data Analyst (Quality Assurance)
Covance LabCorp Company
Pune , INDIA/USA (Remote)
2019.09 - 2021.08
- Leading the team of 6 member within the team responsible for training on various clinical database and reviewing ICSR to perform quality improvement report for analyst.
- Perform quality check for case reports as per client defined key performance indicators ensuring accurate information is captured and reported as per FDA/EMEA guidelines
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Compiled periodic safety update reports for review by senior management team members.
- Processing of Spontaneous serious/non-serious case reports such a MedWatch forms, adverse event report, EV human cases, telephonic contact forms: study sources such as patient support program, marketing research programs and E2B cases
- Conducted literature searches to identify safety signals for specific drugs or classes of drugs.
- Clinical Data analysis - Data Entry, Triage, MedDRA coding of events, Medical history, labelling and Indication analysis, Individual Case safety reports (ICSR), Narrative writing
- Product Quality Complaint handling and interaction with Quality Assurance team.
Drug Safety Data Analyst (Pharmacovigilance)
A Covance LabCorp
Pune , India
2017.08 - 2019.09
- Provide phone support to healthcare professionals and patients, involving receipt and tracking of medical inquiries, capturing adverse events, product quality complaints and other type of calls as required
- Execute drug safety data management processes - a combination of call intake, case intake, triage, case entry, medical coding, peer review, Case follow up, report preparation and submission to regulatory authorities
- Conducted root cause analysis of complex cases involving multiple factors that could have contributed to an adverse event.
- Investigated serious adverse events reported through various sources like literature search or post-marketing surveillance studies.
- Conducted literature searches and evaluated published clinical trials data related to safety issues of drugs or products.
- Performed medical coding using MedDRA to accurately assign terms to individual cases.
- Assisted in training team members on relevant topics such as Global Safety Reporting Guidelines and Good Pharmacovigilance Practices.
Jr. Research Associate
Maharaja Sayajirao Laboratory
Vadodara
2017.01 - 2017.08
- Characterization of Transgenic tobacco lines over-expressing tomato polyamine Biosynthesis
- Expertise in the use of Electronic Lab Document Management System (eDMS) software
- Laboratory Analytical Experience, Gene Alteration, Culture preparation, Aliquoting, Data Review, Review SOP, PCR test
- Managing laboratory information management system File-Maker database.
- Hands on experience on lab instruments Autoclave,HPLC, LAF, PCR, Spectrophotometer, Gel Electroscopes, Gene transfer method, Vortex, Centrifuge, Shaker, Compound microscope, Autoclave, Media preparation, lab data analysis
Education
Master of Science - Pharmaceutical Regulatory Affairs
South East Technological University
Carlow, Ireland2022-10
Bachelor of Science - Biotechnology GPA (9/10) A Grade
Dr. D.Y. Patil Biotechnology & Bioinformatics Institute
Pune, India2017-05
Skills
- Quality Improvement
- Data Analysis
- Quality Review/Quality Assurance
- Sampling / Culture preparation
- Laboratory Testing
- GMP/GCP/GLP
- FDA/ICH Guidelines
- SOP Development
- Data Interpretation
- Problem-Solving
- MS Office
- Data Entry
- Staff Mentoring
- Team Collaboration
- Decision-Making
- Technical Writing
PROJECTS
- Master's Project: Pharmacovigilance to understand the marketing authorization of medicinal products and how it is regulated between Ireland & India, 2021-01-01, 2022-12-31
- Bachelors Project: (Specialization in Molecular and Micro biology) Characterization of Transgenic tobacco lines over-expressing tomato polyamine Biosynthesis., 2017-01-01, 2017-12-31
Hobbies and Interests
- Chess
- Cricket
- Hiking
References
References available upon request.
Timeline
Patient Scheduling Representative (Remote)
Relatecare Healthcare
2021.11 - 2022.09
Sr. Drug Safety Data Analyst (Quality Assurance)
Covance LabCorp Company
2019.09 - 2021.08
Drug Safety Data Analyst (Pharmacovigilance)
A Covance LabCorp
2017.08 - 2019.09
Jr. Research Associate
Maharaja Sayajirao Laboratory
2017.01 - 2017.08
Quality Control Analyst 02 (Sample Management)
Janssen Sciences Ireland Cork
2023 - 2023.12
Master of Science - Pharmaceutical Regulatory Affairs
South East Technological University
Bachelor of Science - Biotechnology GPA (9/10) A Grade
Dr. D.Y. Patil Biotechnology & Bioinformatics Institute
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