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Click here or scroll down to respond to this candidateCandidate's Name
Profile:PHONE NUMBER AVAILABLE EMAIL AVAILABLE Tampa, FLPhysician with 5 years of experience in Drug safety and Pharmacovigilance. Proficient in Individual Case Safety Reports (ICSRs) Processing for investigational and post-marketed drugs, Signal Detection, Aggregate Reporting, and Risk Minimization Strategies. Profound knowledge of FDA, EMA, MHRA, PMDA, TGA, CIOMS, ICH-GCP, and GVP guidelines. Exhibits solid acumen in functioning seamlessly either independently or within collaborative teams. Acquisitive, coupled with organizational finesse, flexibility & meticulous attention to detail. Displays an unwavering commitment to meeting stringent internal and external timelines with utmost precision.Performed ICSR (Individual Case Safety Report) processing activities, including triaging and analyzing content for expectedness, seriousness, causality assessments.Leveraged medical background and experience to integrate case-related information including medical conditions, lab results and procedures, and SUSAR cases, to craft comprehensive SAE narratives.Determined the reportability of cases to local and international regulatory authorities and submission of cases in a timely manner per respective reporting requirements.Demonstrated adeptness with advanced signal detection tools like Empirica and Vigibase, efficiently contributing to Aggregate Reports, PSUR/PBRER, and PADERs.Raised SAE queries to Investigative sites, CRAs as needed.Performed appropriate clinical assessments and ensured compliance with SDEA and other global regulatory reporting requirements.Proficient in using MedDRA, WHODD and writing concise case narratives. Education:Bachelor of Medicine Bachelor of Surgery 2011-2016 INDIA NTR UNIVERSITY OF HEALTH SCIENCESAdvanced International Pharmacovigilance & Argus Safety Certification CCRPSCertificate Program in Advanced Drug Safety and Pharmacovigilance Medipharm Experience:Pharmacovigilance Scientist Astellas Pharmaceuticals Chicago, ILMay 2021 PresentProcessed and reviewed Serious Adverse Events (SAE) and SUSAR cases to ensure accurate and consistent data entry from source documents (spontaneous, PMS, clinical trials), with emphasis on timelines and quality.Page 2Leveraged sophisticated signal detection techniques, including disproportionality analysis and Bayesian data mining, to objectively identify potential safety signals from extensive safety datasets.Conducted a comprehensive review and assessment of aggregate data, including PSUR (Periodic Safety Update Report) and DSUR (Development Safety Update Report), to identify safety signals and emerging concerns.Experienced in crafting and implementing comprehensive Risk Evaluation and Mitigation Strategies (REMS) to minimize potential risks effectively.Conducted in-depth medical reviews of adverse event reports to ensure medical accuracy and coherence.Leveraged diverse medical field expertise, encompassing disease pathology, physiology, pharmacology, oncology, immunology, and therapeutics, to assess the clinical relevance of adverse events.Contributed to the preparation of root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.Initiated corrective and preventive action (CAPA) measures following review of root cause analysis with senior drug safety personnel.Demonstrated acquisition expertise and adeptly navigated audits and inspections.Ensured seamless coordination and performance of external vendors in adverse event handling, data entry, follow-up requests, and literature submissions. Maintains rigorous oversight, upholding accuracy, compliance, and timely reporting through collaborative vendor partnerships.Spearheaded the formulation, negotiation, setup, and compliance of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) with co-developers, co- marketers, and external partners, ensuring alignment with regulatory guidelines and internal standards.Took the lead in training local Patient Safety staff and other internal teams on PV obligations within PVAs, PSPs, and MRPs, contributing to enhanced understanding and compliance.Effectively supervised and led a pharmacovigilance team at Astella Pharmaceuticals, overseeing efficient case processing, signal detection, and regulatory compliance. Simultaneously, provided mentorship and training to junior team members, fostering their professional development while elevating the overall proficiency and productivity of the team. Pharmacovigilance specialist (QC reviewer) Covance Princeton, NJMay 2019 - Apr 2021Reviewed narratives for medical coherence and also providing comments in accordance with companys requirements.Compiled, Reviewed and Quality Checked Individual Case Safety Reports (ICSR) for serious adverse events (SAE) and non-serious adverse events for completeness, consistency, accuracy and clarity.Identified SUSAR cases (Causality and expectedness assessment) based on product knowledge and medical judgement.Contributed to Safety Meetings and Joint Safety Meetings by providing case summaries from Post- Page 3Marketing and Clinical Trial CasesUpdated data sheets for upload to safety database as per current RSI updatesWorked closely in co-ordination with other departments in proper gathering, evaluation, medical assessment and follow-up of individual case safety reports.Communicating and interacting effectively within and across all therapeutic teams, and within functional team management as appropriate.Evaluated the source document for completeness and extracted relevant information from the source document.Performed duplicate case search and accurately captured patient, product, and event data in Oracle Argus safety 8.0.Triaged and coded medical history, laboratory and other investigational test results, adverse event terms using MedDRA and WHO drug dictionaryWrote accurate and detailed clinical case narratives ensuring that all the relevant information is presented in the chronological order of occurrence.Actively participated in process improvement initiatives, contributing ideas that led to 20% reduction in case review turnaround time.Accurately captured listedness/expectedness of adverse events researching USPI and company core data sheet.Generated queries using ARGUS interface for clarification, resolving and forwarding to next work flow and communicated to out-side sources to retrieve the required information on the case report.Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests.Performed appropriate case follow-up, generating and requesting follow-up letters.Responsible for detailed evaluation of the case and routing it to the Medical reviewer for companys comment and Reporting.Participated in contributing towards Aggregate Reports, PSUR/PBRER and PADERs.High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc.Performed any other drug safety related activities as assigned; Mentoring team members and assisting with the preparation of relevant training material. Physician Kurnool Heart and Multi-Speciality Hospital IndiaMar 2016- Feb 2019Skilled in diagnostic procedures, including physical examination, laboratory testing, & imaging studiesProficient in medical record systems and other healthcare information technology & Contributed to clinical research.Skills:Medical Skills and Attributes: Quality Patient Care Medical Records Clinical Research Data Analysis Disease Pathology Physiology Pharmacology Oncology Immunology Therapeutics Page 4Departmental Management: Skillfully developed departmental goals, objectives, standards of performance, policies, and procedures.Pharmacovigilance & Safety Reporting: Experienced in Oracle Argus Safety 8.3, AEs/SAEs reports, spontaneous, regulatory authority, literature and clinical trial case reports.Regulations & Guidelines: FDA, EMA, MHRA, PMDA regulations, ICH-GCP, HIPAA guidelines and GVP Module VI Guidelines. Knowledge in expedited and periodic reporting timeline requirements set by regulatory agencies.Case Processing and Data Management: Hands-on expertise in end-to-end case processing of serious and non-serious cases (unsolicited and solicited reports) in Pharmacovigilance databases such as ARGUS, ARGUS Affiliate and ARISg IRT. Experience in review and reconciliation of ICSRs for inconsistency check.Medical Review Experience: Conducted comprehensive medical assessments of adverse event reports, ensuring medical accuracy and coherence, and provided expert medical insights to enhance safety signal evaluationSignal Detection & Aggregate Reporting: Proficiently employ advanced signal detection tools, including Empirica and Vigibase, to discern emerging safety concerns and trends within pharmacovigilance data. Actively contribute to the meticulous preparation of comprehensive Aggregate Reports, PSUR/PBRER, and PADERs.Agreement Negotiation and Management: Negotiated, set up, and managed Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) with stakeholders, ensuring regulatory compliance and internal standard alignment.Audits and Inspection: Performed as the focal point during audits and inspections, showcasing adeptness in navigating regulatory scrutiny and ensuring compliance.Negotiation Skills: Applied strong negotiation skills in direct communication with co- developers, co-marketers, partners, and vendors for effective agreement formulation and maintenance.Multilingual Proficiency: Demonstrated excellence in English and Spanish, facilitating effective communication with stakeholders.Page 5Training and Development: Utilized expertise to train and mentor local Patient Safety staff and internal teams on pharmacovigilance obligations within agreements, enhancing overall compliance.Compliance Monitoring: Developed and implemented systems and processes for monitoring External Party compliance with PVAs, contributing to adherence to global quality procedures.Vendor Management & Collaboration: Expertise in coordinating and overseeing external vendors for adverse event handling, data entry, follow-up requests, and literature submissions, maintaining accuracy, compliance & timely execution through collaborative partnerships, while fostering cross-functional cooperation and efficiency.Soft Skills: Natural negotiator, Team player, Inquisitive process enhancer, Analytical with Strong attention to details & Dynamic Leadership.Leadership & Training: Natural leader with a flair for mentoring and training junior team members, enhancing overall team proficiency and productivity.Computer Skills: Proficient in Argus, MedDRA, WHODD coding & MS Office Suite PowerPoint, Word, Excel.Certifications:HIPAA CertifiedCCRP (Certified Clinical Research Professional), SoCRAICH GCP TrainingCertification of participation in critical care for Clinical training, TACT academy, ChennaiEducational Commission for Foreign Medical Graduates (ECFMG)DIA Pharmacovigilance certificate |
