Durga Malleswari Robbi
Regulatory Affairs Intern at Rx Bandz- Claim this Profile
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Bio
Manogna Kuchibhotla
Durga showed a tremendous leadership skills during the project at Trust Multispecialty Hospitals. She organized several conferences pertaining to pharmacovigilance and regulatory affairs’ importance. She has amazing communication skills with strong attention to detail. She never compromised in taking challenges where she had to perform multiple tasks in a short period of time. She did her project on anesthesia department, I was really impressed with the way she gathered the critical information and managed to bring the specialists in one place to learn even though its not her expertise. It was fun to work and learn with Durga.
Manogna Kuchibhotla
Durga showed a tremendous leadership skills during the project at Trust Multispecialty Hospitals. She organized several conferences pertaining to pharmacovigilance and regulatory affairs’ importance. She has amazing communication skills with strong attention to detail. She never compromised in taking challenges where she had to perform multiple tasks in a short period of time. She did her project on anesthesia department, I was really impressed with the way she gathered the critical information and managed to bring the specialists in one place to learn even though its not her expertise. It was fun to work and learn with Durga.
Manogna Kuchibhotla
Durga showed a tremendous leadership skills during the project at Trust Multispecialty Hospitals. She organized several conferences pertaining to pharmacovigilance and regulatory affairs’ importance. She has amazing communication skills with strong attention to detail. She never compromised in taking challenges where she had to perform multiple tasks in a short period of time. She did her project on anesthesia department, I was really impressed with the way she gathered the critical information and managed to bring the specialists in one place to learn even though its not her expertise. It was fun to work and learn with Durga.
Manogna Kuchibhotla
Durga showed a tremendous leadership skills during the project at Trust Multispecialty Hospitals. She organized several conferences pertaining to pharmacovigilance and regulatory affairs’ importance. She has amazing communication skills with strong attention to detail. She never compromised in taking challenges where she had to perform multiple tasks in a short period of time. She did her project on anesthesia department, I was really impressed with the way she gathered the critical information and managed to bring the specialists in one place to learn even though its not her expertise. It was fun to work and learn with Durga.
Credentials
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Introduction to FDA Human Drug Review and Approval Basics
FDAAug, 2023- Nov, 2024 -
World of compliance overview
FDAAug, 2023- Nov, 2024 -
Medical writing
PHARMACOURSES LTD
Experience
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Rx Bandz
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Intern
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Sep 2023 - Present
• Research scientific studies to support Rx Bandz regulatory process including FDA and DEA regulations. • Produce documentation and reports in support of Rx Bandz’s regulatory filings and applications. • Maintaining a deep understanding of new and existing federal and state regulations that may impact the company’s products and processes, using that understanding to standardize all business operations and establish clear, documented protocols. • Communicating regulations, procedures, and policies as necessary Reviewing marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance to regulations. • Suggesting courses of action to help the company maintain compliance Show less
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CHEARS | Innovating with technology
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India
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Higher Education
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1 - 100 Employee
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Freelance medical information writer
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Apr 2020 - Dec 2022
• Produced highest quality informational documents by maintaining a high level of product expertise. • Assisted with project related administrative tasks, created writing deliverables for clinical journal manuscripts, and clinical journal abstracts. • Strategically written and edited documents. Accelerated content exposure by 60%. • Effectively managed complex medial writing projects by promoting collaborative work environment. • Produced highest quality informational documents by maintaining a high level of product expertise. • Assisted with project related administrative tasks, created writing deliverables for clinical journal manuscripts, and clinical journal abstracts. • Strategically written and edited documents. Accelerated content exposure by 60%. • Effectively managed complex medial writing projects by promoting collaborative work environment.
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Trust Multispecialty Hospitals, kakinada
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Andhra Pradesh, India
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Clinical Pharmacist Intern
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Oct 2021 - Oct 2022
• Collaborated with healthcare professionals to drive promotions aimed at optimizing health outcomes by conducting prescription error monitoring. • Implemented strategies for detecting and managing adverse drug reactions, conducting medication history interviews, providing drugs and poison information, offering patient counseling, and implementing therapeutic interventions. • Identified and reported adverse events to Pharmacovigilance department. • Collaborated with healthcare professionals to drive promotions aimed at optimizing health outcomes by conducting prescription error monitoring. • Implemented strategies for detecting and managing adverse drug reactions, conducting medication history interviews, providing drugs and poison information, offering patient counseling, and implementing therapeutic interventions. • Identified and reported adverse events to Pharmacovigilance department.
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Research Intern
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Apr 2021 - Sep 2021
• Enrolled 48 subjects, while administering patient questionnaires and abstracting medical records. • Assisted with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols. • Participated in evaluating patients for compliance related to protocol, assisted with collecting, extracting, coding, and analyzing clinical research data, generated reports, and review to ensure the validity of data. • Provided project specific status reports, attended cross functional meetings, coordinated, and scheduled meetings. • Proven ability to plan and schedule multiple priorities in a concurrent fashion and operating in a fast – paced environment. Show less
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Education
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2022 - 2024
Northeastern University
Masters in Regulatory Affairs, 4.0 -
2016 - 2022
Jawaharlal Nehru Technological University
Doctor of Pharmacy - PharmD, (Pharmacology, therapeutics, Clinical research, clinical pharmacy, toxicology) -
2014 - 2016
Sri Chaitanya College of Education
Bi.p.c, Chemistry, human biology, botany
Community
