Regulatory Affairs
Resume:
Divya Padala M.D
**** ******** *****, *************** ** 60110
************@*****.***
SUMMARY:
Proficient in ARGUS Data Safety submission and Narrative Writing
Thorough understanding and knowledge of MedDRA coding, pharmacovigilance practices for both Clinical Trial and Post marketing AE reporting
Well versed with GVP-ICH guidelines
Knowledge in approval submissions to the FDA
ECFMG certified medical graduate with strong clinical knowledge
Self-driven, highly motivated medical professional with excellent leadership and organizational skills
Works well in stressful environment to meet deadlines by leading teams in an independent, self-directed manner
EDUCATION:
Windsor University School of Medicine. St. Kitts & Nevis – Doctor of Medicine (M.D)
University of Illinois at Chicago – Premedical Sciences
PROFESSIONAL LICENSE AND CERTIFICATES:
4C Pharma Solutions Pharmacovigilance Certificate
Educational Commission for Foreign Medical Graduates (ECFMG Certificate)
oUnited States Medical Licensing Exam Step 1 Basic Sciences
oUnited States Medical Licensing Exam Step 2 Clinical Knowledge
oUnited States Medical Licensing Exam Step 2 Clinical Skills
PROFESSIONAL WORK EXPERIENCE:
4C Pharma Solutions 01/2017 - Current
Pharmacovigilance Associate Piscataway, NJ
Work on ORACLE ARGUS Safety Database and use MedDRA coding with sample cases on consistent basis
Entry and revision of applicable information into the global safety database regarding SUSARs
Preparation of narratives for MedWatch Forms (FDA 3500A)
Triaging, assessment for case validity, labeling, outcome, causality and seriousness for individual case safety reports (ICSR)
Update and enter appropriate data into clinical database and ensure data was captured according to departmental SOPs
Narrative writing following CIOMS V guidelines
Assist with quarterly and annual global regulatory safety reports (PSURs)
Virginia Commonwealth University 05/2017 - Current
Clinical Safety Associate Richmond, VA
Perform quality review and check cases for discrepancies related to labeling and narrative writing
Input Adverse Events related to devices and medication used in pharmaceuticals into Safety Databases derived from source documents
Prepare Narratives summarizing the events for spontaneous cases through assessment of all source documents
Conduct literature search for AE reporting and case assessments on weekly basis by preparing narrative writing using various source documents
Albany Medical Center 06/2013 – 12/2016
Consultant
Maintained communication to sustain compliance with current regulations
Discussed projects at hand with healthcare professionals in the field of Cardiology
Described the steps needed to collect AEs and enter in Safety Database on a consistent basis
Advised on following company’s SOPs in a timely manner to assist the first author for drafting manuscripts
Represented physicians in recruiting other trainees to participate in the ongoing projects
RSA Medical 01/2012 – 12/2012
Medical Case Manager Naperville, IL
Reported all AEs to the underwriting department for Medical review and accuracy of diagnoses
Applied medical knowledge while conducting thorough patient history in assessing Adverse Drug Reactions (ADR)
Worked under stressful environment by leading individual groups to meet deadlines
Created presentations and participated in teaching lectures
University of Connecticut 03/2009 – 05/2009
Internal Medicine Externship Hartford, CT
Documented patient reported AEs while obtaining medical history and conducting physical exams
Formulated differential diagnoses and management plans based on the outcome of history and physicals
Prepared power point presentations on various medical cases and managed patient needs
Participated in teaching rounds and all educational lectures
University of Connecticut 01/2009 – 02/2009
Ambulatory Clinic Externship Hartford, CT
Obtained clinical data, performed focused physical exams, formulated diagnostic and therapeutic plans with team members
Screened for ADRs based on patient histories and physicals for chart review
Presented clinical cases on a daily basis to senior physicians
Attended various educational conferences and mentored medical students
Jackson Park Hospital 08/2005 – 05/2007
Clinical Clerkships Chicago, IL
Clinical experience in various specialties by assisting physicians with procedures, responsible of taking detailed patient history and formulated diagnosis and treatment plans
Participated in categorizing different AEs to derive an appropriate diagnosis with team members
Completed monthly assessments given to test medical knowledge and clinical skills
Clinical Clerkship Experience: Internal Medicine, Cardiology, Neurology, Immunology, Obstetrics/Gynecology, General Psychiatry, Family Medicine, General Surgery, Emergency Medicine, Pediatrics
LANGUAGES:
Native Fluency: English, Hindi, Telugu
Communicator Level: Spanish, Punjabi, Gujarati
RESEARCH EXPERIENCE:
Albany Medical Center 07/2010 – 01/2012
Clinical Research Coordinator Albany, NY
Well versed in research methodology and writing code, analyzing data in SPSS and Stata Statistical packages
Wrote up the protocol for Institutional Review Board (IRB) approval
Conducted analysis of data, statistical analysis, literature search and writing up first draft of manuscript
Provided research support by synthesizing and analyzing the data, perform comparative analyses from former published data
University of Connecticut 03/2009– 05/2010
Clinical Research Coordinator Hartford, CT
Responsible for MedDRA coding, and writing Narratives for individual cases
Participated in design, execution and evaluation of the research project, including literature review, data integration, and analysis
Responsible for drafting preliminary reports prior to the preparation of manuscripts
Presented research findings at academic settings to senior investigators
University of Southwestern Texas 03/2008 – 10/2008
Clinical Research Coordinator Dallas, TX
Performed literature search, Data Collection and Outcome Analysis
Contributed to team decisions about research directions
Ensured the validity and reliability of data at all times
Assisted in writing a book chapter in ‘Peripheral Interventions’
Reviewed updated literature on a consistent basis
PRESENTATIONS/POSTERS:
Padala D, Mota P, Khera S. ‘Streptococcus Bovis Type II endocarditis. Poster presented at: ACP regional Connecticut chapter in November 2010; Southington, CT.
Parwani P, Padala D. ‘It may not just be "Crack"’. Poster presented at: ACP regional Connecticut chapter in November 2010; Southington, CT.
Padala D, Pavuluri V. (2010, April).’ No Meat No Treat: Why a Biopsy is Imperative?’ Oral presentation at Society of General Internal Medicine (SGIM) New England Regional Meeting at Brown University, RI.
Pavuluri, V, Padala D (2010, April). ‘Aortic Dissection’. Oral presentation at Society of General Internal Medicine (SGIM) New England Regional Meeting at Brown University, RI.
HONORS AND AWARDS:
Recipient of Best Oral Presentation in Biochemistry ‘Electron Transport Chain’
Recipient of Best Oral Presentation in Biochemistry ‘Pathophysiology of Atherosclerosis’
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