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Click here or scroll down to respond to this candidateCandidate's Name
Street Address
EMAIL AVAILABLE PHONE NUMBER AVAILABLESUMMARY Pharmacovigilance operations specialist with over 5 years of extensive safety reporting experience to Regulatory Authorities, Ethics Committees, CIRBs, IRBs and Investigators with working knowledge of global regulatory requirement Vast experience with the processing of adverse events and SUSARs from clinical trials and post- marketing surveillance In-depth knowledge of FDA and ICH guidance, GCP regulations, EU Directives, CIRB and country specific safety reporting requirements Respected team leader who proactively finds areas to optimize processes to elevate productivity Effective administrator and articulate communicator with the ability to lead multiple studies, while keeping great relationships with sponsors and internal team Extensive multitasking experience with high attention to detail Excels in managing operations in both an administrative and clinical setting Ensuring compliance, organization, and storage of records within regulatory standards Extensive experience with Microsoft Office products Clinical Trial, Post-Marketing Surveillance, Oracle Argus, APEX, CTMS, Veeva Vault, Medidata, EDC Rave, US- FDA, ICH, GCP, MedDRA, WHO Drug, Aggregate Reports, MedWatch, CIOMS, Sound Medical Knowledge, Protocol Review, Final Clinical Safety Report, Safety Plan Writing/Review, Global guidelines/requirements CERTIFICATIONSGood Clinical Practice (GCP) AccreditationCertified Professional Coder (CPC)EXPERIENCEIQVIA / IQVIA Biotech March 2019 PresentOperations Specialist 2 9/ 2023 Present IQVIA Trial Master File (TMF) Subject Matter Expert, team training, and oversight for end-to end SAE case processing and safety reporting Overseeing the delivery of the Safety services defined in the scope of work for multiple studies Assess Lifecycle Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement (Including US, European Union, Health Canada, Latin America, Asian Pacific, TGA Australia) Prepare and test e-Submissions via gateways Generate and transmit xmls for submission via EVWEB and ICSR Submission portal (MHRA) Maintain oversight of case workflow throughout the entire lifecycle of the documents Perform quality control of safety data Attend/take part in project team meetings and provide feedback to operations manager on any challenges/issues or successes Liaise with different functional team members, to address operational project issues Generate status reports and provide project metrics while also calculating and entering monthly metrics into relevant databases Create Safety Management Plan (SMP) and continue ongoing annual review of plans Mentor less experienced and newer staff members, while identifying and implementing process efficiencies on projects Problem solving safety reporting issues with the project team and/or Sponsor Senior Safety Reporting Specialist 8/2021 9/2023 Serve as the Safety Reporting Lead for medium to high complexity clinical drug trials independently Review the safety budget and scope of work/deliverables with the Sponsor at study start-up Creating/Contributing to the development of the Safety Reporting/Safety Management Plan Tracking and maintaining CA/EC/CIRB approvals and end of trial notification letters Working with regulatory agencies and ethics committees for their country-specific reporting requirements Managing routine project level deliverables and communications with minimal supervision/oversight Monitoring submission compliance and collaborating with the project team to support on-time submissions Continuously maintaining documentation to ensure audit readiness and taking part in audits Assess, prepare, submit, and track expedited, periodic and investigator safety reports for drug studies to CAs/ECs/CIRBs per SOPs, SMP, and country specific reporting requirements Submit SUSARs via EVWEB and other country-specific portals, as applicable Conducts peer QC of submissions, final packages, and uploads to the electronic trial master file (eTMF) Aids in developing/implementing process improvements including providing team training Safety Reporting Specialist 1/2021 8/2021 Deliver global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements, and SOPs Operations Specialist 1 3/2019 1/2021 Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations, SOP's and internal guidelines. Regional Anesthesia Associates, LLC April 2018 March 2019 Surgery Coder/ Team Lead 4/2018 3/2019 Review and assess the complex medical records and accurately code the primary/secondary diagnoses and procedures using ICD-10 and CPT coding convention Review and process all medical record documentation and accurately code the diagnoses and procedures Maintain a thorough understanding of anatomy and physiology, medical terminology, and disease processes Cary Orthopedics January 2014 April 2018Certified Processional Coder (CPC) 6/2015 4/2018 Review and analyze patient records to ensure all procedure codes are correct and follow CPT guidelines Abstract information from documentation and translate physician's notes into medical and diagnosis codes Perform data entry with keen attention to detail for all correct correlating diagnosis and modifiers Administrative Coordination Specialist 1/2014 6/2015 Gather and review patient, clinic, and insurance records for accuracy Participate in organization's team to affect process improvement EDUCATIONAppalachian State University Boone, NC December 2013 Bachelor of Science in Exercise Science Minor in Psychology and Biology Graduated with Honors Graduated summa cum laudeWake Technical College Raleigh, NC August 2015 Certified Professional Coder (CPC) |
