Praveen Thummala
USA
Summary
An accomplished pharmacovigilance specialist with a strong foundation in drug safety, regulatory compliance, and health data management. With over 9 years of experience in the pharmacovigilance domain, I have successfully overseen the entire Individual Case Safety Report (ICSR) process, written and reviewed aggregate reports, managed report submissions, implemented electronic reporting rules, and executed large-scale data extractions, showcasing my adeptness in precise handling of safety data. Holding a master’s degree in health informatics, I am equipped with advanced tools to further health data management. Keen to actively contribute to projects that maintain the highest standards of safety data in the healthcare industry.
Overview
9
9
years of professional experience
Work History
Senior Drug Safety Associate/PV Operation leader
Mirati Therapeutics, A BMS company
, USA
01.2022 - Current
- Oversee daily quality assessments of ICSRs from vendors including narratives, product and medical coding, and other case fields, to identify discrepancies in relation to source documents
- Provided support during inspections conducted by regulatory agencies relating to drug safety matters.
- Evaluate regulatory reports required for ICSR submissions on an individual case basis and liaise with the submission team regarding reporting requirements
- Conduct SAE reconciliation with relevant personnel from CROs, vendors, business partners, and team members, offering safety insights and guidance to resolve discrepancies
- Respond to any queries related to case processing during CRO/partner reconciliations
- Review, update, and uphold data entry guidelines as applicable
- Act as the Study Lead to address inquiries related to SAE reconciliation activities, SAE forms, DSURs, IDMC, and submission timelines
- Present SAE reconciliation metrics and compliance updates during cross-functional team meetings
- Assist in literature surveillance activities
- Execute user acceptance testing in Oracle safety database development environment for data entry changes prior to implementation in production
- Facilitate signal detection and evaluation activities in line with SOPs and guidelines
- Create and maintain Pharmacovigilance SMPs, SOPs, PV agreements, and work instructions as required
- Ensure audit readiness and assist with regulatory inspections
- Participate in other Pharmacovigilance and Risk Management activities under the guidance of senior PV staff as needed
- Assess study-specific regulatory reporting requirements, configure reporting rules in Argus for SUSAR and periodic reports, and monitor compliance for submissions
- Review change controls and vendor invoices to offer cost-effective solutions
- Evaluate PV agreements with business partners and vendors
- Deliver case processing and protocol training to vendors
Safety Data Analyst: Pharmacovigilance Operations
Novartis Pharma
, USA
10.2018 - 12.2021
- Drafted, modified, and executed SQL queries in TOAD, a graphical user interface tool to retrieve ICSR data from the Argus Safety database
- Analyzed data to identify reasons for submission failures, and then to regenerate, transmit, and submit newly generated reports to global health authorities (USFDA, EMA, MHRA etc.) in CIOMS paper, electronic XML, and HL7 formats
- Managed the central safety reporting mailbox, responding to ad-hoc queries from country organizations (COs) regarding reportability
- Manually generated and transmitted ICSR safety reports to COs upon their requests
- Created test cases to conduct testing for new or modified database configurations, contributing to paper-to-electronic reporting switch
- Handled 12 bulk safety data transfer requests from license partners, delivering data in both paper and electronic formats as requested
- Hosted and documented minutes of meetings for scheduled meetings with License Partners (LPs) and COs for various projects
- Responsible for reconciliation of drug safety databases and clinical study databases for ADR reporting and follow up
- Participated in a special project addressing corrections in safety data for clinical trial cases as requested by the trial’s principal investigator
- Trained and mentored candidates on handling reporting mailbox and performing ICSR submission tasks
Senior Drug Safety Associate
CLARIO
, USA
02.2017 - 09.2018
- Processed over 2000 spontaneous, clinical trials, literature, health authority, and legal ICSRs within the ARGUS safety database
- Performed follow-up with reporters to obtain missing information, ensuring the comprehensive completion of the ICSR
- Used MedDRA (Medical Dictionary for Regulatory Activities) for coding adverse events, and WHO-DD (WHO Drug Dictionary) and Company Drug Dictionary (CDD) for coding medicinal products
- Written clear and concise narrative for ICSRs including oncology clinical trial cases
- Handled a comprehensive quality review of diverse safety cases to ensure data integrity and completeness
- Handled case deletions and closures
- Managed the client’s central mailbox for receiving adverse events, conducted triage, and completed the book-in process
- Conducted daily reconciliation of all received emails to ensure no information was overlooked
- Downloaded ICSRs and handled triage of regulatory reports from VAERS, a USFDA website
- Managed regulatory health authority databases like VAERS and MHRA for ICSR downloads and drafted SOPs for the same
- Drafted SOPs for mailbox handling, triage and book in of ICSRs received from health regulatory authorities
- Lead the triage team by delegating and evaluating the tasks carried out by the team
- Authored and finalized aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, and line listings
- Participated in internal and external audits and inspections, as required
- Provided training and mentorship to 13 associates on triage, data processing, and quality control guidelines
Drug Safety Associate
VigiMedsafe (now PPD)
Hyderabad, India
11.2015 - 01.2017
- Conduct/Lead ongoing literature safety surveillance for marketed and investigational products
- Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review
- Performed thorough review of full-text articles to identify ICSRs, with the excluded literature directed toward safety signal detection
- Followed up with literature authors to obtain missing ICSR information, ensuring the completeness of safety reports
- Documenting and processing serious adverse events (SAEs) by ensuring complete and accurate case information is entered into the database
- Triage of incoming cases to assess seriousness, expectedness, and causality, prioritizing case processing according to the timelines outlined in standard operating procedures (SOP) and regulatory requirements
- Processing literature cases by extracting relevant information from publications and categorizing them as separate cases
- Assisting the medical monitor with the documentation and processing of source documents, as well as retrieving accurate medical information
- Conducting safety-related training for non-departmental staff within the company
Education
Master of Science - Health Informatics
Indiana University - Purdue University Indianapolis
Indianapolis, USAPHARM D (Doctor of Pharmacy) - Pharmaceutical Sciences
Andhra University
Vishakhapatnam, INDIASkills
- Vendor management compliance monitoring
- Literature search and analysis
- Central Safety Mailbox Management
- Knowledgeable in ARGUS and ArisG
- E2B case intake handling
- Triage and booking safety reports
- WHO-DD and CDD Drug Coding
- Proficient in MedDRA Coding
- Event seriousness, listedness, and causality assessment
- Processing literature, legal, and SUSAR cases
- Clinical Narrative Evaluation
- Generating follow-up letters
- Quality Assessment in Data Entry
- ICSR generation and submission troubleshooting
- Safety database compatibility testing
- Quality review presentations
- Signal management and detection activities
- Familiarity with ICH-GCP guidelines
- SAE reconciliation expertise
- Adherence to SOPs and regulations
- Proficiency in MS Office tools
- Strong analytical skills
- Excellent communication skills
- Effective multitasking and prioritization
- Attention to detail, strong scientific, analytical, and conceptual skills
- Project management capabilities
Timeline
Senior Drug Safety Associate/PV Operation leader
Mirati Therapeutics, A BMS company
01.2022 - Current
Safety Data Analyst: Pharmacovigilance Operations
Novartis Pharma
10.2018 - 12.2021
Senior Drug Safety Associate
CLARIO
02.2017 - 09.2018
Drug Safety Associate
VigiMedsafe (now PPD)
11.2015 - 01.2017
Master of Science - Health Informatics
Indiana University - Purdue University Indianapolis
PHARM D (Doctor of Pharmacy) - Pharmaceutical Sciences
Andhra University
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