Drug Safety Specialist

Madhuri Lokapally

Austin, Texas 484-***-**** ad7pzf@r.postjobfree.com linkedin.com/in/madhuril Drug Safety Specialist, Senior Drug Safety Associate, Drug Safety Scientist

With 6 years of experience in drug safety, I achieved a 30% increase in adverse event reporting and optimized database efficiency by 25% in 6 years. I improved safety reporting efficiency, demonstrated the ability to resolve 95% of case issues, mentored new staff, and exceeded ICSR processing targets, resulting in heightened regulatory compliance.

SKILLS

●Pharmacovigilance and Drug Safety: Adverse Event Reporting, Analyze Complex Data, CAPAs, Development of Safety Narratives, Duplicate search, Literature Review and Analysis, MedDRA coding, Medical Devices, Pharmacovigilance Regulations, Regulatory Reporting, Risk Management, Safety Case Processing, Safety Database Management (ARGUS, ARISg), Signal Detection, Triage, WHO-DD

●Medical and Scientific Knowledge: Clinical Trial Protocols, Drug Development Process, Medical Terminology, Pharmacology, Understanding of Medical Devices

●Analytical and Technical Skills: Data Analysis, Database Management, Excel and MS Office Applications

●Communication and Collaboration: Effective Communication, Interdisciplinary Collaboration, Stakeholder Engagement, Training and Mentoring

●Regulatory and Compliance: Compliance Monitoring, Good Documentation Practices, Knowledge of FDA and EMA Regulations, Understanding of ICH Guidelines

●Problem Solving and Decision Making: Attention to Detail, Critical Thinking, Decision-Making Abilities, Problem-Solving Skills

●Time Management and Organization: Multi-tasking, Prioritization Abilities, Time Management Skills

●Continuous Learning and Adaptability: Adaptability to Changes in Regulations or Processes, Continuous Learning, Flexibility in Handling Workload

WORK EXPERIENCE

Vama Innovations. LLC Austin, Texas, United States ·Remote Drug Safety Specialist Contract 02/2023 - 05/2024

●Achieved 30% rise in adverse event reporting by enhancing vigilance and timely reporting, resulting in improved medication safety and regulatory compliance.

●Identified 30% more safety concerns through comprehensive safety assessments, enhancing risk identification and ensuring product safety.

●Resolved 95% of case issues by adeptly communicating with stakeholders, ensuring rapid resolution and operational continuity.

Parexel Hyderabad, Telangana, India · Hybrid Drug Safety Specialist Full-time 12/2019 - 06/2022

●Achieved 25% increase in Argus system efficiency, while maintaining 100% accuracy in safety case processing, leading to improved productivity and safety monitoring capabilities.

●Improved safety reporting efficiency, leading to a 30% decrease in response time, ensuring timely and accurate reporting for the team.

●Enhanced training program: Mentored new staff, resulting in a 20% increase in operational efficiency and consistency, improving overall drug safety processes.

VigiMedsafe (a division of PPD) Hyderabad, Telangana, India ·On-site Drug Safety Associate Full-time 10/2017 - 11/2019

●Exceeded ICSR processing targets by 20%: Established an efficient triage system, leading to on time submissions to regulatory authorities and heightened regulatory compliance.

●Achieved 100% accuracy in data entry and coding: Streamlined maintenance of WHO-DD drug safety database, leading to increased precision in regulatory adherence.

●Enhanced case processing efficiency by 25% through rigorous self-assessments, resulting in reduced errors and improved data accuracy.

Vaagdevi Institute of Pharmaceutical Sciences, Kakathiya University Graduate Research Student 05/2017 - 10/2017

●Worked on a research project entitled, “THERAPEUTIC DRUG MONITORING FOR OLANZAPINE IN SCHIZOPHRENIA”.

EDUCATION

Doctor of Pharmacy - PharmD in Clinical pharmacist

Vaagdevi institute of pharmaceutical sciences 11/2011 - 11/2017

CERTIFICATIONS

Certificate Course in Pharmacovigilance Aggregate Reporting

Udemy

PROJECTS

THERAPEUTIC DRUG MONITORING FOR OLANZAPINE IN SCHIZOPHRENIA 05/2017 - 10/2017 Investigated therapeutic drug monitoring of Olanzapine in Schizophrenic patients with respect to concentration versus dose relationship.

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