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Candidate's Name , M.D.Email: EMAIL AVAILABLEPhone number: PHONE NUMBER AVAILABLEOver 7 years of experience in Pharmacovigilance and educational/clinical expertise as a Drug Safety Associate and Medical Reviewer, working with Clinical Trials, Post-Marketing and Medical Literature. Responsible for overseeing specific aspects of adverse event processing, medical review, aggregate reporting and reporting for assigned marketed products. US Citizen, willing to relocate.SUMMARY OF EXPERTISE:*In-depth knowledge of various types of case processing including spontaneous, clinical and literature cases. Experience with Literature, Clinical Trials, Post-Marketing Individual Case Safety Reports (ICSRs), and related Regulations*Safety physician for investigational product studies, products in literature as well as products in post-marketing (PM)*Serious PM, Clinical Trials and Literature case processing, quality and medical review steps handled for global cases*Performed Medical Review of ICSRs in the safety database, including determining the expectedness, seriousness, and causality of adverse events against various product labeling documents, and narratives including company comments*Worked with the project teams to ensure consistency in the assessment, recording and coding of safety events (e.g., serious adverse events (SAEs), adverse events (AEs), work with Regulatory Affairs to ensure timely reporting of AEs and SAEs including expedited reporting*Coded complex medical and treatment data reported in Drug Safety sources and Literature articles to a standard terminology in accordance with ICH endorsed guidelines and corporate coding conventions to allow for meaningful evaluation and analysis*Produced Safety Queries as needed for clarification of reports*Reviewed medical terminologies and drug terminologies according to project specific coding conventions including MedDRA coding and WHO Drug Dictionaries, Package Inserts (PIs), Investigator Brochures (IB) and Company Core Data Sheets (CCDS) including complying with standard operating procedures (SOPs)*Interacted on a regular basis with others in Medical Review, Pharmacovigilance (PV) Safety Science, Case Managers, PV Managers, and Project Managers to identify process improvement strategies and communicate project status updates*Expertise in AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, medical review conventions and guidelines, clients procedures and international drug safety regulations including GCP and ICH guidelines on safety and efficacy, New PV legislation, FDA guidelines, and US Code of Federal Regulations (CFR) guidelines*Therapeutic areas worked  Oncology, Gynecology, Reproductive Sciences, Immunology, Cardiovascular, Metabolism, Infectious Diseases, Pediatrics, Psychiatry, Pulmonology, and GastroenterologyEDUCATION:M.D. (Doctor of Medicine)University of St. Eustatius School of Medicine, Netherlands AntillesB.A., Economics-MathematicsEmory University, Atlanta, GACERTIFICATIONS:Educational Commission for Foreign Medical Graduates (ECFMG) Certification issuedOctober 3, 2011SKILLS:*Proficient in of global safety databases like ARGUS Safety*Expertise in Microsoft (MS) Office Suite / 365 (Word, Excel, PowerPoint, Outlook), MS Teams and Adobe AcrobatAWARDS/HONORS:*On The Spot Award for literature assessment volume and accuracy, Jan 2018*Literature Training Award for incoming literature trainees, Dec 2018*IQVIA Spotlight Award for triage lead and data entry, Jun 2021*IQVIA Spotlight Award for triage lead and quality review, Jan 2022*IQVIA Spotlight Award for triage lead and quality review, Jun 2022*IQVIA Spotlight Award for triage lead, data entry and quality review, Dec 2022*IQVIA Ovation Award for triage lead, data entry and quality review, Oct 2023PUBLICATIONS:Lin, D.; Hoffmann, D.; Pulivarti, V.; Abendroth, C.; Pulivarti, B. Sitagliptin Caused Acute Drug Induced Interstitial Nephritis. Consultant360, 53: 444-446, June 2014.PROFESSIONAL EXPERIENCE:Operations Specialist II March 2021  August 2024 IQVIA, Durham, NCReviewed and processed Safety data as a Subject Matter Expert (SME) from various sources including spontaneous and solicited post-marketing, literature and clinical trial cases on time for a very large client.Performed data entry in databases, coding relevant medical terminology and writing descript narratives.Generated queries including for SAEs and AECIs/AESIs pertinent to the case.Drove case closure including regulatory report submissions and drafts including MedWatch and CIOMS within assigned deadlines and driving case closure of invalid cases.Performed thorough quality control of post-marketing, clinical trial and literature cases processed.Triage Lead and SME for coding, coding conventions and seriousness of cases, mentored and trained incoming team members in triage, performed triage of multiple incoming cases from Book-in, and clarified cases with internal Medical Reviewers and the client.Participated in in both internal team meetings as well regular external project team case review meetings in discussion of coding conventions and seriousness assessment of cases and comments from line listings while liaising directly with the client.Exposure to reconciliation and non-serious post-marketing line listings for the client.Associate Pharmacovigilance (PV) Physician July 2020  Feb 2021PrimeVigilance USA (formerly Ashfield Pharmacovigilance), Cary, NC April 2017 Feb 2021Provided medical review of clinical trial studies including SUSARs, literature and post-marketing safety reports across client products.Reviewed and comprehensively analyzed aggregate data including Periodic Adverse Drug Experience Reports (PADERs), new adverse events, and/or frequency or outcome of known adverse events associated with clients products.Participated in client meetings, project-related training sessions, worked closely with drug safety associates, pharmacovigilance managers and project managers to achieve a high level of client satisfaction.Performed medical review for annual toxicology report ICSR cases for multiple clients and products.Interacted with Medical Monitoring in introductory role.Case Manager II, Medical Literature Assessment Team April 2019  July 2020Reviewed literature summaries and articles via Medline/Embase and PubMed and assessed for seriousness, expectedness, causalities, duplications, and recorded results in literature tracking documentation as well as quality review of fellow team members' assessments of literature surveillance.Regular meetings with PV management, project managers, and administration to discuss team strategies and planning including medical literature management and the creation of the literature team.Trained incoming team employees on literature assessment and triaging and secondary quality review of assessments.As a Subject Matter Expert (SME), helped other teams with questions and assessments of literature summaries and articles.Attended client visit meetings and audits as a senior team representative and participating in CAPA Management for select literature cases.Pulled literature articles from article database for review and for different teams' reviews.Participated in ICSR management including Quality Control/Review (QC) and organization of annual toxicology review for various products of multiple clients.Drug Safety Associate / Case Manager II October 2017  April 2019Contract Case Manager April 2017  October 2017Triaged incoming reports for initial assessment of seriousness, expectedness, and causality, for reports from post marketing, solicited, direct lift, and literature sources.Performed Quality Review and Data Entry of ICSRs including spontaneous, solicited, direct lift, and literature cases as well as literature article assessments as Lead for client.Comprehensive ICSR processing of incoming serious and non-serious adverse events (AEs) in accordance with company guidelines, US FDA regulations and international guidelines.Assisted Safety Science with regular Quarterly Reports and Periodic Adverse Drug Experience Reports (PADERs) through Data Lock Point (DLPs) communications.Networked with the Medical Information (MI) with weekly MI reconciliations.Performed weekly line listing reconciliations with clients for third-party products.Worked routinely with Medical Review on discussion of final assessments and modifications of cases.Monitored and general oversight and addressing of inquires in central mailbox related to ICSRs for post-marketing.Participated in annual toxicology report case processing and Quality Review.Drug Safety Associate / Contract Case Manager Feb 2017Ashfield Healthcare, Ivyland, PATriaged incoming reports after initial assessment of seriousness, expectedness, and causality, for reports from post marketing sources.Comprehensive processing of incoming serious and non-serious adverse events (AEs) in accordance with company guidelines, US FDA regulations and international guidelines.Worked on management of adverse events /serious adverse events that occur with the client marketed products.Reviewed each adverse event report for accuracy and consistency.Accurately coded incoming serious and non-serious adverse events (AEs) using MedDRA terminology and coding of drugs with WHO-Drug Dictionaries.Assessed follow up, locking, and archiving of serious and non-serious cases.Wellness Advisor/Practice Management Associate Sep 2015  Sep 2016 Millville Internal and Specialty Medicine, Millville, NJWellness specialist offered preventive care and lifestyle recommendations.Performed preventive screening tests including wellness questionnaires, cognitive testing and depression screening, posturography, and critical care assessment including autonomic nervous system function and ankle brachial index tests.Studied patient charts, coordinating with staff, and scheduling patients for regular and wellness visits based on pre-qualifying conditions.Involved in organizing/uploading patient files from paper to Electronic Medical Records (EMR)/Electronic Health Records (EHR) software.Offered free on-site blood pressure/glucose screenings in area senior care facilities.Patient care and counseling and formulation of care and compliance plans in Chronic Care Management program for Medicare patients.