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Click here or scroll down to respond to this candidateCandidate's Name , RN BSc.EMAIL AVAILABLELinkedIn: LINKEDIN LINK AVAILABLEPHONE NUMBER AVAILABLE Morganville, NJPharmacovigilanceSummaryResilient, self-motivated drug safety professional dedicated for over sixteen years to pharmaceutical safety and efficacy through monitoring and preventing adverse effects in patients. Skilled communicator proficient at synthesizing, interpreting, and conveying complex data and information in comprehensive documentation and reporting. Analytical, detail-oriented time manager able to resolve issues, prioritize, and deliver on high-demand workloads in fast-paced environments with the highest level of professionalism and integrity.QUALIFICATIONS SUMMARYAccomplished at collecting and recording evidence of adverse events, creating standard operating procedures (SOPs), literature and litigation screening/processing, and individual case study reports.Keen collaborator with internal and external partners to resolve issues and ensure accurate case creation and processing in compliance with local and global legislation. Developed activities related to quality compliance and training.Extensive experience contributing to and assisting with litigations, investigations, and corrective and preventative action (CAPA), including root cause analysis and data analysis.PROFESSIONAL EXPERIENCEConcentra Urgent Care, Jamesburg, NJ, 2020-2022Onsite Lead at Abbott Labs in Freehold & Princeton, NJTeam Lead for COVID testing and positive results teaching of employees; following and implementing all CDC and government safety and testing protocols, including data entry into the Communicable Disease Reporting and Surveillance System (CDRSS) for the NJ Department of Health (DOH); and patient teaching.General Electric Healthcare Pharmaceutical Diagnostics, Marlborough, MA 2018 2020Business Transformation Lead (Remote)Led and directed the Argus Upgrade (8.1.2.5)-J (Japan) E2B R3 implementation project, including collaboration with GEHC/IQVIA and Daiichi Sankyo to resolve issues. Drove the writing of the business process summary (BPS) and Statement of Issue (SOI) for case processing post-transfer of market authorization holder (MAH) from license partner to GEHC in Japan.Streamlined global database ARGUS, updated standard operating procedures (SOP), data handling conventions (DHC), and BPS to align with new European Medicines Agency (EMA) pharmacovigilance regulations, including work instructions, job aids, and training materials. In addition, collaborated with Japan to align with the Pharmaceuticals and Medical Devices Agency (PMDA).Global Compliance Consultant (Remote) 2017-2018Spearheaded all maintenance of the global pharmacovigilance (PV) network for local safety offices and distributors via ARGUS, including PV personnel contact information, PV agreement status, local regulatory reporting requirements, and training records. Reconciled safety data in PV network tracking logs, ensuring compliance of submissions to GE Central Safety Unit and global regulatory agencies. Assisted colleagues with compliance monitoring, metrics, performance data, investigations, and CAPAs, including root cause analysis of non-compliant single-case reports. Collaborated with internal and external partners to resolve issues and develop training activities for quality compliance and training.Recognized for success as the Global liaison between General Electric Pharmaceutical Diagnostics and distributors, vendors, and license partners, producing the highest rate of compliance on record.Sanofi-Aventis, Bridgewater, NJ 2016 2017Case Management Regulatory OfficerLed the reportability assessment and regulatory outreview of individual case safety reports (ICSRs) using Oracle/Aers Aware before distribution and submission to the EMA. Collaborated with the inbound team to ensure accurate case creation in accordance with current legislation. Validated and processed determination of Global Dear Investigation letters (DILs) released to affiliates and clinical scientific operations for transmission to investigators. Ensured compliance with global regulatory rules, International Conference on Harmonization (ICH) guidelines, and on-time submission of ICSRs and DILs.Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings.Drug Safety Associate Consultant Experience:G & W Laboratories Inc., South Plainfield, NJ 2016Manager, Pharmacovigilance (PV) & Regulatory AffairsServed as the medical information specialist and managed all aspects of safety issues regarding marketed products, including triage of adverse event reports, physician, pharmacy, consumer complaints and inquires, adverse experience (AE), serious adverse experience (SAE) review, data entry, coding, and narrative writing via the FDA portal and ARGUS 8.0. Ensured transfer of critical information from initial and follow-up source documents for AE reports and managed case reports to regulatory requirements. Assisted internal and external partners with reconciliation, prepared and submitted US Periodic Adverse Drug Experience Report (PADER), meeting regulatory requirements. Sourced, reviewed, and processed weekly literature citations for reporting and collection of safety information. Continually participated in internal and external training programs and conferences, remaining current with emerging tools, processes, and technologies about product safety and risk management.Collaborated with senior management to develop pharmacovigilance unit and infrastructure, including creating and implementing ARGUS 8.0 database, PV phone line, PV email box, and SOPs. Assisted in creating the ARGUS database, enabled compliance with current FDA regulations, significantly reducing late cases, audits, and fines.Bristol Myers Squibb, Hopewell/Pennington, NJ 2016Safety ReviewerConducted all aspects of reviewing standard forms and source documents from post-marketing pregnancy cases previously entered into the ARGUS 7.0 database. Added critical information within service level timelines and deliverables, including missing or discrepant patients, AEs, products, and laboratory or historical data. Assessed cases for the creation of additional case(s) or deletion from ARGUS. Reassessed pregnancy off-label use of ICSRs for CAPA from an EMA audit. Updated case information in ARGUS, completing appropriate coding of patient AEs, history, and laboratory data via MedDRA dictionary. Entered or corrected suspect/concomitant products using Product and WHO drug dictionaries and labeling per ICSR requirements. Constructed or merged chronological case narrative summaries, performed system and E2B validation checks before appropriate routing of cases, and performed final quality checks (QC) for off-label cases. Also, Scheduled cases for submission to stakeholders by running regulatory reports and attaching queries and actions for ICSRs. Collaborated with the safety review team and medical review safety physicians to resolve issues and undertake tasks outside this role.Resolved and circumvented issues with the FDA by expediting case processing to meet CAPA deadlines.General Electric Healthcare, Princeton, NJ, and Trevose, PA (Remote) 2014 2015Global Compliance ConsultantDrove compliance and performance data monitoring in global safety database ARISg 6.3.1.0.05, including data entry. Assisted with investigations and CAPAs, including root cause analysis of non-compliant ICSRs. Created and corrected PV SOPs, organized PV training documentation, and assessed employee curriculum vitae (CV) for current compliance. Collaborated with internal and external partners on quality, compliance, and training issues. Conducted final review of data entry regarding serious and non-serious incoming reports, correcting narrative, drug coding, patient history, lab data, and adverse events. Triaged incoming global and domestic AE reports from literature, legal, and spontaneous sources. Performed initial triage assessment of seriousness, expectedness, causality, and reportability. Executed receipt of drug safety phone calls and completed proper intake of information. QCd the data entry of non-serious and serious incoming reports. Identified missing or discrepant information and completed follow-up.Additional Contracts:Senior Safety Associate, Astellas Pharma Project, inVentiv (Syneos), Somerset, NJ, 2014 2015Safety Associate II, inVentiv (Syneos) CAPA for Gadolinium Contrast Class Action - Somerset, NJ, 2013 2014Drug Safety Specialist/Literature/Oncology Lead Case Processor, Celgene, Berkeley Heights, NJ, 2011 2013Drug Safety Specialist, Schering Plough/Merck, Springfield, NJ, 2009 2011Safety Surveillance Associate, Pfizer Pharmaceutical, Inc., Bridgewater, NJ, 2006 2009Inpatient Registered Nurse Case Manager, Horizon Cross Blue Shield of NJ, Wall, NJ, 2005 2006MDS Pharma Services, Per Diem Safety Nurse Phase One Clinical Drug Trials, Neptune, NJ, 2005Performed events according to study protocol and as assigned by the study manager, performing vital signs, EKGs, blood draws, and identifying, treating, and reporting AEs / SAEs to the Clinical Research Associate (CRA) and Project Leader.Offsite Manager/Occupational Health Nurse Manager, US Postal Service 1998 2006Implemented the pre-employment Medical Assessment Process (MAP), including Drug / Vision Screening and Medical Health Histories of potential USPS Candidates. Triage employees for injuries in open medical units for all USPS locations in NJ. Performed special projects, including health fairs, vaccination programs, and TB Testing.Spearheaded Anthrax Screening with the Centers for Disease Control and Prevention (CDC) for Anthrax exposure and dispensed appropriate medications. Conducted bioterrorism training with the state of NJ, County of Middlesex, and the Township of Edison, NJ to decontaminate large populations for potential future attacks.EDUCATIONBachelor of Science in Psychology - September 2023Capella University, Minneapolis, MNGraduated Summa Cum Laude (GPA 4.0)Associate of Science in NursingRutgers University / Middlesex County College Newark / Edison, NJCERTIFICATIONS TRAININGBasic Life Support - American Heart Association Jun2024Bioterrorism Training - Anthrax Screening - Centers for Disease Control and Prevention (CDC)Collaborate Institutional Training Initiative (CITI) Certification in Human Research May 2025Registered Prof. Nurse Licensure in NJ / Multi-StateTECHNICAL SKILLSARISg ARGUS MedDRA WHO Drug Microsoft Office: Excel, Word, PowerPoint Ellipses SharePoint |
