BHARAT TADURI
Coventry
Summary
Motivated individual with MSc in Global Healthcare Management and PharmD degree, bringing two years of dedicated experience in pharmacovigilance, specializing in case processing, quality review and triage. Skilled in Aris G, Argus, AgXchange, IRT, my expertise extends to ICSR case management, Health Authority (HA) Submission – via E2B/CIOMS, Coding clinical data (Medical conditions, surgical procedures, adverse events and medications) with coding dictionaries as MedDRA, WHOdd, EudraVigilance Medicinal Product Dictionary (EVMPD). Dedicated to producing high-quality deliverables and take pride in work. My objective is to join an experienced team, contributing my skills and expertise to meet team goals.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
Work History
Safety Science Coordinator I
Labcorp Drug Development
Bangalore, India
12.2021 - 01.2023
- Successfully completed initial reviews and seriousness assessments within Global Inbound Receipt System (GIRS), determining case criteria for inclusion in safety database.
- Performed data entry of key fields, including ICH date, coding of products/protocol, adverse event (AE) verbatim, and patient demographics.
- Conducted thorough duplicate searches to determine correct action for Individual Case Safety Report (ICSR), whether it is initial or follow-up report.
- Managed 11 E2B cases and over 50 health authority cases per day with increased productivity in case count.
- Initiated translation requests from stakeholders, such as Business Partners (BP) and Local Safety Officers (LSO).
- Managed AE/Product Quality Complaint referral process.
- Completed full case information in database, ensuring accuracy and completeness through quality reviews.
- Finalized remaining case data entry, including narrative or auto-narrative, manual coding, labeling, and approval numbers as required.
- Conducted quality reviews of ICSRs, ensuring accuracy and incorporating corrections when applicable.
- Liaised with appropriate stakeholders, including Global Medical Safety Operations Physicians (GMSOP) and Labcorp Pharmacovigilance Physicians (PVPs), to clarify information required for case processing.
- Handled various case processing activities, including ICSR unblinding, Serious Adverse Event (SAE) reconciliation, deviation memo preparation, deletion requests, and reviewed protocol updates for accuracy.
- Managed operational activities, including monitoring quality of ICSRs and tracking various information and metrics.
- Demonstrated due diligence by obtaining follow-up information from consumers, healthcare professionals, and other manufacturers.
- Reconciled data and changed global receiver unit for all incoming cases in database, ensuring allocation to appropriate region (ASPAC, EMA, LATAM).
Safety Science Analyst
Labcorp Drug Development
Bangalore, India
12.2020 - 12.2021
- Conducted comprehensive case intake and triage of safety information and reports from various sources, both spontaneous and clinical trial-related.
- Wrote detailed patient narratives and coded adverse events with precision using MedDRA, particularly for Marketed products.
- Submitted expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, project personnel within agreed timelines.
- Played crucial role in processing and submitting expedited and periodic reports to worldwide regulatory agencies and other recipients, prioritizing submissions within regulatory and study-specific timelines.
- Worked within Quality Management System framework, adhering to Standard Operating Procedures (SOP) and departmental Work Instructions (WIs).
- Built and maintained positive relationships across functional units, particularly in cultivating strong PSS relationships.
- Ensured compliance of operations with governing regulatory requirements.
Clinical coordinator
Basaveshwar Teaching & General Hospital
kalaburagi, India
08.2019 - 10.2020
- Over 14 months, managed patient care at BTHG Hospital, providing health screenings, counselling 300 patients, and reviewing prescriptions for errors and interactions.
- I gained experience in navigating institutional review board (IRB), assisting in data management, statistical interpretation, and research report preparation.
- I also assisted in patient visits, data collection, and administration, ensuring clear communication with patients and ensuring informed consent
- Reviewed content of all drug packaging and labelling to ensure completeness and accuracy.
- Partnered with physicians and other members of healthcare team to optimize patient care thorough effective use of medications.
Education
Master of Science - Global Healthcare management
Coventry University
Coventry 01.2023 - 01.2024
Doctor of Pharmacy (Pharm D) - Pharmaceuticals
Rajiv Gandhi University of Health Sciences
India 06.2014 - 10.2020
Skills
- Proficient in AgXchange and Aris G for streamlined data management
- Attention to detail in all tasks
- Strong auditing skills for accuracy and compliance
- Dedicated to working extended hours when necessary
- Incorporates constructive feedback with a positive mindset
- Computer literate, skilled in navigating various software
- Drug safety protocols and implementation
- Adheres to Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP)
- Well versed with ICH-GCP guidelines
- Flexibility to adjust and accommodate shifting priorities
- Proficient in MS Office for efficient data handling and analysis
- Executes comprehensive quality reviews ensuring precision
- Thrives in collaborative environments, actively contributing to teamwork dynamics
LICENSE AND CERTIFICATIONS:
- Certified Registered Pharmacist in KARNATAKA STATE PHARMACY COUNCIL, India.
- Certificate on GCP (GOOD CLINICAL PRACTICE) : A beginners Approach held on 18th SEPT 2017 conducted by KBN Medical college.
- Attended workshop on current perspective of Pharmacovigilance & Hemovigilance held on 28th & 29th SEPT 2018 in NET RAICHUR.
Timeline
Master of Science - Global Healthcare management
Coventry University
01.2023 - 01.2024
Safety Science Coordinator I
Labcorp Drug Development
12.2021 - 01.2023
Safety Science Analyst
Labcorp Drug Development
12.2020 - 12.2021
Clinical coordinator
Basaveshwar Teaching & General Hospital
08.2019 - 10.2020
Doctor of Pharmacy (Pharm D) - Pharmaceuticals
Rajiv Gandhi University of Health Sciences
06.2014 - 10.2020
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