Kasturi Banerjee
Safety Science Specialist
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Hardworking and passionate job seeker with strong organizational skills eager to secure Pharmacovigilance positions. Ready to help team achieve company goals.
Overview
7
7
years of professional experience
3
3
Certifications
3
3
Languages
Work History
Safety Science Specialist, Safety Science Coordinator-II & I, Safety Science Analyst, Drug Safety Intern
Fortrea Development India Pvt. Ltd. (previously Labcorp Drug Development)
1 2020 - Current
- Managed the receipt, intake and processing of all adverse event reports reported from a clinical trial, executed routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
- Assisted in the processing and reporting of expedited safety reports (ESRs) to Clients, Regulatory Authorities, Ethics Committees, Investigators and Fortrea Project Personnel and follow-up with sites, investigators and client regarding follow-ups if required.
- Processing of ICSRs, case narrative preparation, data entry into safety databases and tracking systems, adverse event and product coding using MedDRA and WHODrug dictionaries.
- Maintenance of Adverse Event tracking systems like Argus and iMedidata RAVE. Set-up and maintenance of project files, core process files and central safety files using CTMS.
- eTMF management for real-time inspection readiness, visibility, and control using Veeva Vault.
- Participated in signal detection, trend and pattern recognition activities, as appropriate, prepare timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
- Demonstrated leadership on projects which enhance team and/or division performance, work with Data Management or client on reconciliation of safety databases, if appropriate, monitor workflow for assigned studies/programs to ensure all deadlines are met.
- Maintained a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance, possess knowledge of other procedural documents, e.g SOPs, etc, that impact the department.
- Assisted in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate, ensured compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Participated in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided. Maintained and distributed a weekly schedule for PSSA staff by pulling the daily and weekly productivity and inventory of the teams.
- Prepared Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under minimal supervision.
- Participated in client or regulatory audits, assisted in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, assisted with the set-up of, and the provision of data to Safety Committees/DSMBs.
- Maintained a strong understanding of safety database conventions or client-specific database conventions, as appropriate and mentored new team members.
Intern
Pharmadeep Remedies
06.2017 - 06.2017
Intern
Syncorp Clinicare Technologies
05.2017 - 05.2017
Education
Master of Science - Pharmaceutical Sciences
KLE College of Pharmacy, Bengaluru
04.2001 -
Bachelor of Science - Pharmacy
School of Pharmaceutical Sciences, SOA, Bhubaneswar
04.2001 -
Skills
ICH-GCP Guidelines
Therapeutic Experience
- Oncology Solid Tumors Multiple Solid Tumors-Phase IIa
- Oncology Breast Cancer Cancer, Breast-Phase IIa
- Hematology Leukemia Acute Lymphocytic-ALL-Phase I
- Infectious Diseases Viral Infection Hepatitis C-Phase IIb
- Hereditary Disorders Genetic Disorders Hereditary Periodic Fevers-Phase IIa
Accomplishments
- Level 2 award for Process Excellence for triage and data entry processes under the Labcorp Global Recognition Program.
- Level 2 award for Client Excellence for a drug and medical devices study under the Labcorp Global Recognition Program.
- Level 1 award for People Excellence for extended support in triage and case processing for a very high-volume study under the Fortrea Global Recognition Program.
- Level 2 award for Process Excellence for triage and data entry processes for a study which successfully received market approval under the Fortrea Global Recognition Program.
Certification
Registered Pharmacist (RPh)
Projects
M. Pharm Thesis: Formulation and Evaluation of Zidovudine Loaded Polymeric Microparticles for Vaginal Delivery.
Paper Presentation at 69th IPC, Chandigarh, 2017: Synthesis and Antibacterial Evaluation of β-Naphthol Derivative Bearing Azosulphonamide Group
Timeline
Intern
Pharmadeep Remedies
06.2017 - 06.2017
Intern
Syncorp Clinicare Technologies
05.2017 - 05.2017
Master of Science - Pharmaceutical Sciences
KLE College of Pharmacy, Bengaluru
04.2001 -
Bachelor of Science - Pharmacy
School of Pharmaceutical Sciences, SOA, Bhubaneswar
04.2001 -
Safety Science Specialist, Safety Science Coordinator-II & I, Safety Science Analyst, Drug Safety Intern
Fortrea Development India Pvt. Ltd. (previously Labcorp Drug Development)
1 2020 - Current
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