Naga Kalidindi
North Liberty
Summary
Senior Drug Safety Specialist with five years of experience in pharmacovigilance. Expertise in data analysis and review of adverse event reports, ensuring compliance with ICH regulations and FDA standards, and committed to patient safety. Strong attention to detail, and effective communication skills. Committed to continuous professional development and learning.
Overview
7
7
years of professional experience
Work History
Drug Safety - Patient Safety Services Specialist I
LabCorp
Princeton
10.2020 - 09.2023
- Manage the receipt and processing of all adverse event reports (AE and SAE reports) reported either spontaneously from any source, or from a clinical trial.
- Data entry, processing, and review of (AE and SAE reports), safety data onto the adverse event database (Argus), and tracking systems.
- Review of adverse events (AE and SAE reports) for completeness, accuracy, and legibility for expedited reporting.
- Write patient narratives for SAE reports, and code adverse events accurately using MedDRA.
- Determine listedness against the appropriate label (for marketed products, if applicable), and ensure consistency in the investigator's causality assessment.
- Identifies clinically significant information missing from the reports, and ensures its collection and follow-up by generating appropriate queries.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines. Prepare MedWatch, CIOMS, and other forms as needed.
- Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Labcorp project personnel, if required, within study-specified timelines.
- Submission of expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Labcorp project personnel, if required and as agreed with the client during study set-up, within study-specified timelines.
- Perform database reconciliation with the Data Management team or sponsor/client as needed.
- Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including the maintenance of adverse event tracking systems, the set-up and maintenance of project files, and central files for documentation.
- Maintain a strong understanding of Labcorp’s safety database conventions, client-specific database conventions, FDA and ICH guidelines, product labeling standard operating procedures, and process guidelines.
- Perform a quality review or peer review of processed reports, and support the line management with trends and actions needed.
- Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs), such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), etc.
- Participate in the generation of monthly status reports and other project-specific reports, ensuring the quality and accuracy of the metrics and data provided.
- Support, train, and mentor less-experienced safety staff in all aspects of case handling and adverse event reporting.
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), guidance documents, and directives associated with safety management, reporting, and pharmacovigilance.
- Assist with the review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans, ensuring optimal efficiency.
- Participate in Labcorp project team and client meetings, as appropriate.
- Prepare and support the coordination of safety study files for archiving at the completion of projects.
- Contribute to root cause analysis, including the CAPA plan development and implementation.
- Support audits and/or inspections preparation.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities, or clients, if applicable, and coordination of endpoint committees.
- Any other duties, as assigned by management.
Drug Safety Associate
LabCorp
Princeton
06.2018 - 09.2019
- Manage the receipt and processing of all adverse event reports, reported either spontaneously from any source, or from a clinical trial.
- Maintain a strong understanding of safety database (internal database and Argus) conventions, or client-specific database conventions, as appropriate.
- Participate in signal detection, trend recognition, and pattern recognition activities, as appropriate.
- Prepare timely pharmacovigilance reports (generate MedWatch, CIOMS) for products and safety issues, including Individual Case Summary Reports (ICSRs) of serious adverse events.
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs), and Periodic Safety Update Reports (PSURs).
- Work with Data Management or the client on the reconciliation of safety databases.
- Support and train less experienced safety staff in all aspects of case handling and adverse event reporting.
- Maintains a comprehensive understanding of Safety Standard Operating Procedures (SOPs), Work Instructions (WIs), guidance documents, and directives associated with safety management, reporting, and pharmacovigilance.
- Ensure compliant safety reporting in accordance with U.S. and international reporting regulations, SOPs, and safety processing guidelines set forth by the departmental management team and the client.
Drug Safety Data Management Specialist
Pfizer
Peapack
11.2016 - 02.2018
- Triaging of cases according to potential adverse events (identifiable patient, identifiable reporter, suspect drug, and adverse event) of suspect and co-suspect products, and further assist the internal teams.
- Scanning, follow-up mailing, and faxing of reports as required.
- Complete case processing, which includes data entry (book-in, duplicate search, data entry, MedDRA coding, narrative writing, case routing). Processing of SUSARs and Special Safety Concern Cases, past drug and pregnancy case splitting, and processing reports regarding vaccines and medical devices.
- Perform a quality review of ICSRs and SUSAR cases: Ensure all safety information is accurate, integrated, and current.
- Case querying: Identification of discrepancies, and implementation of corrective actions. Send queries to internal teams (PSSR teams, medical reviewers) and external teams (licensing partners' appropriate teams) for clarifications regarding serious and non-serious cases.
- Experience of working in teams: Collaborate within a multi-disciplinary team on safety-related issues.
- Following appropriate drug and device safety reporting requirements regarding the collection and maintenance of safety records.
- On-time delivery of assigned responsibilities.
- Regular completion of training, including technical training, shadowing, and/or mentoring others, and soft-skill development.
- Mentoring of other Drug Safety Associates, as assigned.
Education
Associate Degree - Advanced Drug Safety & Pharmacovigilance
Sollers Inc.
Edison, NJ10-2016
Master of Science - Masters of Pharmacy, Pharmaceutical Technology
Shri Vishnu College of Pharmacy
Andhra Pradesh, India12-2013
Bachelor of Science - Bachelor of Pharmacy
Sri Ramachandra College of Pharmacy
Tamil Nadu, India12-2011
Skills
- SAE case processing and review
- MedDRA coding and narrative writing
- Regulatory compliance
- Team collaboration
Languages
English
Full Professional
Telugu
Native/ Bilingual
Hindi
Limited
Timeline
Drug Safety - Patient Safety Services Specialist I
LabCorp
10.2020 - 09.2023
Drug Safety Associate
LabCorp
06.2018 - 09.2019
Drug Safety Data Management Specialist
Pfizer
11.2016 - 02.2018
Associate Degree - Advanced Drug Safety & Pharmacovigilance
Sollers Inc.
Master of Science - Masters of Pharmacy, Pharmaceutical Technology
Shri Vishnu College of Pharmacy
Bachelor of Science - Bachelor of Pharmacy
Sri Ramachandra College of Pharmacy
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