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Click here or scroll down to respond to this candidateCandidate's Name , PharmDBilingual: English, French: MD Street Address Cell: PHONE NUMBER AVAILABLE EMAIL AVAILABLE US Government Security Clearance: Public TrustObjective: Experienced Clinical Pharmacist with at least 10+ years in clinical optimization of therapy management, research, drug safety and pharmacovigilance seeking a position in the AD-660 series with the Food and Drug Administration (FDA). Apply clinical pharmacy knowledge and pharmacology to monitor drug applications and supplementals in NDA and BLA licensing, as well as provide responses to queries with generated data analysis and reports for regulatory compliances Collaborate across teams to analyze, and present data, communicating track and report information to optimize technical expertise and leadership for operational programs Implement staff optimization and management policies, consistent with state and federal regulations, as well as practice standardsTECHNICAL & CORE COMPETENCIES Clinical Pharmacist Clinical pharmacy - Subject Matter Consultant (SMC); Drug Information - formulary review and protocol development, pharmacokinetics, pharmacodynamics, hepatic monitoring of medication therapy management- antibiotic stewardship, chemotherapy, HIV, anticoagulation, specialty medications, pain management; data analysis and reporting presentationsTECHNICAL & CORE COMPETENCIES Drug Safety Pharmacovigilance skills Analytically execute clinical trials, with diverse teams - communicating reports onsignal detection; trained in CT- CAE in SUSAR; Aggregate reporting - SOPs and regulatory compliance FDA, EMEA Proficient in Oracle Argus Safety (Version 8.1 Safety Suite); MedDRA coding (Version 21.0), MedDRA Coding, IME List, ICH/CIOMS, WHO-UMC, CFR(312), CFR (314), E(6), E(2)b submission Experienced in ICSRs: triaging, Validity assessment, expectedness, data entry, event - causality assessment, and narrative writing; utilizing MedDRA coding, IME Listing, CTCAE - WHO-UMC dictionary; Drug Development processes, application of ICH-GCP, GCP, GVP guidelines of ADME data; FDA, EMEA - spontaneous and aggregate reporting; Inclusive and comparative updates of ADME data of IB in SUSAR; DSURs, PSURs consistent with GVP, ICH E6 (GCP); regulatory compliances Collaborate in processing, and CTCAE ranking in reporting of Serious Adverse Events (SAEs), compliance with FDA/EMEA/Japan regulations: SUSAR, PSUR/PBRER/PADER, as eCTD to regulators; update and ADR ranking in (IB)/PI/SmPC Expertise in written and oral communications with FDA, ICH-GCP guidelines, and Canada, EMEA regulatory compliance; problem solving; clinical and analytical skills to implement and monitor disease states - physical and laboratory; Human Subject Protection safety and quality control monitoring and protocol IRB compliance, ICH/CIOMSEDUCATION New Investigator Certification Bristol Myers Squibb Training Program Jan. - completion in Aug. 2024 Doctor of Pharmacy, Univ. of The Sciences Philadelphia Coll. of Pharmacy, Philadelphia, PA Advanced Certification in Drug Safety / Pharmacovigilance - Masters Degree, Sollers College, Edison, NJ License s Sciences Naturlles, (B.Sc.) Universite de Yaounde Nat. Sciences, Biochemistry Pharmacy Software: Civilian and GovernmentVista, Script Pro, MHS Genesis EPIC Willow CERNER Allscripts McKesson Medication Manager MediTech Omnicel Pyxis Knowledge of Tricare policies; Essentris CHCS AHLTA GSL BLS certified Microsoft Office Suite - Excel, Power Point OneNote Oracle Argus Safety - Suite 8.1 VisioCLINICAL PHARMACIST EXPERTISE AND OPERATIONAL EXPERIENCE Clinical Pharmacist Long-Term Care Pharmacy - 40 Hrs; 08/2023 Present Veterans Administration Hospital & Medical Center - Baltimore, MD ; Pharm Pro Inc Evaluate, assess therapy appropriateness, and enters orders from Pending File Care-In-The-Community(CITC) working across teams of Out-of-Network Providers towards processing and optimization in treatment of acute and chronic diseases Manage as well as recommend Diabetes medication per A1c goals, consistent with ADA, JNC 8 Hypertension Guidelines and Algorithm, and KDIGO guidelines Communicate relevant information to Providers, timely - adapting therapies consistent with pharmacy principles, and clinical pharmaco-dynamics toward optimizing treatment effectiveness, reducing adverse events, and applying Pharmacy standards, principles, and protocols to improve compliance and avoid treatment failure Identify and assess Poly-pharmacy, manages (anti-psychotics, neuroleptics, migraine and pain management, diabetes medication and prevent duplicative therapy, including A1c reduction goal medication therapies Intervene in appropriateness of renal dosing of antimicrobial therapies and appropriateness in treatment(Antimicrobial Stewardship and Treatment Guidelines); Respiratory management appropriate use of short-acting bronchodilators per GOLD Standard, for example Gold Standard guidelines implementation and management of adverse events, drug interactions, contraindications, therapy recommendations, as well as communicating recommendations to Clinical Pharmacist Specialists and other Providers. Ambulatory Care Clinical Pharmacist Specialist - Credentialed Provider, (D. H. A. Dept. of the Army - MAHC Ft Leavenworth, KS 40 Hrs March 2021 Oct. 20212 Developed and reported personalized treatment plans, monitoring therapies, ordering and interpreting lab data and other pertinent data to optimize patient outcomes in Diabetes, Hypertension, dyslipidemia management; other co-morbid conditions Managed Diabetes Treatment and drug classes, considering A1c and Treatment goals per ADA, JNC 8 Hypertension Guideline Algorithm, and KDIGO guidelines Interfaced and provided education to patients and their families about therapies e.g. Diabetes Medications and Reduction in A1c goals per Medication Class- relevant for informed decision in shared decision treatment options with treatment team; for example, teaching Diabetes Medication Classes and their effects on A1c Reduction Goals to patients Provided analysis and reports on (MUE) of anti-psychotics in DSM-V diagnosis, PolyPharmacy Co-chaired Antimicrobial Stewardship Program (ASP); responsible for its implementation and reporting in compliance towards reduction in resistance of current formulary, consistent with The Joint Commission ComplianceReported - oral and written communication in drug information presentation, Antimicrobial Stewardship Program implementation as presentations to other providers and physicians and P&T Committee meetings; most current updates and information on specific disease states and treatment guidelines in optimizing Antimicrobial Stewardship Protocol in Outpatient MTF Developed criteria for drug utilization evaluations, data collection, trending reports, and other quality assurance metrics towards ensuring appropriate and safe drug utilization Participates in audits and quality assessment and monitoring For example, Presenting Antimicrobial appropriateness in UTI Treatment and Outcomes Outpatient MTF Presented reports to P&T Committee about functions and assignments as required, e. g. Antimicrobial Use Outpatient Treatment MTF; ADR monitoring, medication error reporting, medication utilization evaluation activities, drug monographs/reviews, et al. Coumadin Clinic Switching anticoagulants to LMWH, DOACs per ASHP Guidelines, consistent with diagnosed clinical conditions; monitoring and managing patients with partnered Clinical Pharmacist. Success target greater than goal metric in Anticoagulation Therapy - processing at-home monitoring INR monitoring devices, monitoring and optimizing INRs in warfarin dosing into sustained therapeutic and clinical and guideline outcomes; knowledge in initiating other DOACs renal dosing, education of other patient factors. Accomplished and surpassed monthly outcome metrics in number of patients managed, other HEDIS measures providing periodic assessment of patients' medication therapy, monitoring, recommending or implementing changes (within the scope of clinical privileges) managing chronic diseases in patients - diabetes, hypertension, hyperlipidemia, Polypharmacy, and Pain Management; Immunizations consistent with Readiness Policy. Peer reviewed other Clinical Pharmacist Specialist colleague on clinical management of patients with periodic monitoring - providing feedback consistent with most current clinical guidelines and evidence based medicineClinical Pharmacist - Univ. of Maryland Med. Systems Vaccine and Infusion Preparation Baltimore, MD February 2021 July 2021 COVID Public Health Program Preparation and optimization in meeting goals in Vaccination Campaign, prepared Infusion therapies to meet ongoing Public Health objectives and goalsDrug Safety and Pharmacovigilance Associate - Sollers College, Edison, NJ 40 Hrs June 2018 - Feb. 2019 Optimize triaging, data entry of Individual Case Safety Reports (ICSRs) - validity assessment, triage, duplicate check, book-in, data entry, events assessment, severity and causality assessment, analysis reporting, follow-up queries and updates of cases to Quality Review, narrative writing, onto E2B completion, FDA compliance Logged, assigned Medidata and case reports for new cases; Applied Anatomical Therapeutic Chemical Classifi-cation (ATC) of drug active moiety into SOC for MedDRA Coding, WHO-UMC / WHO-DD to analyze Medida-ta, applying Pharmaco-epidemiologic and clinical signal detections of ADRs AESI and CTCAE ~ Four years expertise in Oracle Argus Safety (Suite 8.1) - communicating and implementing technical and regulatory information - GCP; GVP - MedDRA coding, WHO-UMC, ICH/ CIOMS, FDA/EMEA, CFR (312;314) - GCP - IRB protocol development & Human Subject Protection in Clinical Trial Implementation; Clinical Analyses - narrative writing; drug discovery processes and therapy - clinical trials with clinical pharmacotherapy and operational excellence, drug and medical information Regulatory Affairs, Labeling - eCTD - AESI, CTCAE - inclusive and comparative updates of ADME data in IB -(SUSAR, PADER/PBRER, DSUR/PSUR), Aggregate reporting; and regulatory compliances of FDA, EMA; Clini- cal Trials in US, Canada, UK, EME; Familiar in Signal Detection - CTCAE, AESI; and Pharmaco-epidemiology Strong Communication skills - oral and written: P&T Presentations, SOP development and implementation, Health- outcomes and policiesMedical Information / Pharmacovigilance Specialist - A-Line Staffing - Alexion Pharmaceuticals, on assignment with the Lash Group, an Amerisource Bergen Consult, Rockville, MD 40 Hrs Mar 2012 - Dec 2013; Oct. 2019 Feb. 2020 Reviewed and presented clinical and medical information, analyzing data & statistics, clinical trials and de- signs to update SLPs, formulary, optimize and provide appropriate clinical information on treatment, clinical pathways, access (to NTDs, INDs, Orphans Drugs/NDA), and FDA Compliance, and GCP, 12 CFR(E6)- 312, 314; 45 CFR 46, Presented scientific information, clinical trials and data analysis to Internal Team members, other members, RAMS- Reviewed, determined, and support through SLPs, SOPs clinical appropriateness of therapies to providers, healthcare providers, prior authorization of HEP-C agents, specialty drug - Soliris PNH & aHUS), other therapies for Hep-C treatments; documented and ranked Adverse Drug Event reporting and ICSR on Patient Safety Reporting (PSR), AESI, CTCAE to document SAEs, ADRs) - ensuring Quality and Safety ADR reporting into Argus Oracle (Version 8.0), implementing WHO-UMC ADRs; MedDRA Coding and IME List in SUSAR (AESI to IB document) compliance, other Aggregate Reporting (group cases) as PADER/PBRER/DSUR/PSURPharmacist - Dept. of Health and Human Services - ASPR/NDMS VA01 - DMAT, Elkridge, MD May 2019 Mar. 2021 Evaluate and implement DUE/DUR and policies, other quality assurance programs, enhance outcomes and cost-benefits in Relief Projects and on-going deployment efforts; consult and update, with advisory recommendations of facilitys pharmacy programs Optimize through monitoring, on-going evaluation of medication regimens, P&T Reviews, DUR of standard and measurable outcomes in antibiotic Multi-Drug Resistance programs Review/analyze, and research publications in providing medication information, clinical appropriateness and dispensing recommendations to providers; education and counseling in current practices Optimize assessments of therapeutic duplication in the programs drug regimens, formularies and testings, im- plement programs in disaster, and dispense medications Subject Matter Expert resource for inter-departmental clinical, contract, and benefit inquiries Clinical Pharmacist - Mt. Wash. Hosp. / Woodmoor Pharmacy, Gwyn Oaks, MD 16hrs April 2014 - Present Pharmacist-In-Charge - Comcare Pharmacy, Bowie, MD 40 Hrs October 2018 - July 2019 Perform utilization reviews to optimize chronic and infectious diseases management, utilizing patients profiles and prescriptions; cycle-fills and compliance in optimization and outcome measures; analyze processing and outcome measures for use in assessing oncology-related patient outcomes, continuum of care, and present im- pact on compliance measures - MTM Review, interpret and evaluate medication orders to identify, prevent and resolve drug-related problems in chronic disease management, oncology, anti-coagulation, HIV therapies; verify/enter medication orders, dis- pense, and recommend pharmacotherapy to physicians, and nurses for optimal treatment outcomes Implement Quality Assurance in Opioid Prescription Compliance Protocols with cross-functional health- care teams, CRISP, and patient and treatment outcome Increase and optimize prior authorization; protocol compliance, collaborate with prescribers, recommend and document clinical interventions, dose adjustments utilizing PCK to manage and optimize phenytoin, CBZ, digoxin, aminoglycosides, clinical guidelines, and compliance in treatment outcomes through pharmacokinetics and dosing of vancomycin, aminoglycosides; enteral and parenteral nutrition - PPN/TPN& USP 797 & 800Lead Clinical Pharmacist - Atlantic General Hospital, Berlin, MD 40 Hrs April 2017 -August 2017 Inpatient Pharmacist - Keesler AFB Medical Center,Biloxi, MS 40 Hrs July 2016 -April 2017 Prospectively reviewed medication profiles prior to rounds, perform rounds, recommending therapy optimiza- tion, and updates; entered, processed, and dispensed medication orders, consistent with pharmacotherapy prin- ciples, assessments and protocols; Chronic Care and Medication Therapy Management, implemented Pain Management and protocol Optimized infection Control implementation in (ICU, Med-Surg Units) through co-ordinating, developing, and monitoring (with other departments) policies and protocols; established Antibiotic Stewardship Program document, implementing drug review and pharmacokinetics implementation policies Enhanced drug information and pharmacy protocols through monthly presentation of pharmacotherapy princi- ples and knowledge in select regimens, MTM, monthly review of medication use, other data and parameters to optimize pharmacokinetics and pharmacodynamics of therapies, reviewed outcomes - policies and procedures Reviewed for appropriateness of care (indications, lab and pertinent parameters, drug interactions, adverse effects, contraindications), and enter medication orders Clin. Pharmacist - (HIV) Chase Brexton Health Clin, Balt., MD (340-b Management) 40 Hrs March 2015 - June 2016 Led and emphasized clinical appropriateness of regimens, Prior Authorizations for HIV, Harvoni protocol for Hep-C treatments, improving operations and clinical evaluation of HAART therapies in indigenous populations Managed operational excellence, implementing pharmacotherapy review of ARV regimens, Adverse Events management and compliance assessment; comprehensive Therapy Management - MTM Implemented pain management protocol, ARVs regimen optimization and compliance, & MTM Managed operations - supply chain, inventory of 340-B accounts and budget - proposals and recommen- dations; Optimized staff performance - feedback and coaching, accomplishing compliance with objectives in increased patient compliance in therapy, improved goals of therapy, enhanced customer satisfaction Pharmacy Manager & Immunizer Pharmacist - Rite Aid, Beltsville, 67 - 70 hr /week June - Oct. 2015 Managed daily operations, increased vaccination campaigns and numbers; inventory, supply chain and personne to improve customer service, wait time decreased, promptness in prior authorizations, and clinical appropriateness in implementing medication safety measures and professional standards; increased turn-around times, and profitability; provided clinical care, patient counseling, and prospective drug use evaluation to patients, Care Team Optimized the accuracy and appropriateness of medication orders filled through completing Drug Utilization Re view, other clinical programs - MTM, optimized immunization update and compliance, including MTM (Medication Therapy Management), DCS (Diabetes Care Review), etc Evaluate significance of signs and symptoms relative to disease processes and recommended modification of drug therapy to prescribers - doses, drug-drug interaction, duplications, adverse effects management and contra- indications Reviewed and resolved patient daily reports for controlled, outdated, and recalled medications; and prescription and profilesClinical Pharmacist - Laurel Regional Hospital, Laurel, MD 30 Hrs October 2012 - October 2014; Clinical Pharmacist - Soliant Health Inc. / Southern MD Hosp, Clinton, MD 40 Hrs May 2009 - May 2012 Prospectively reviewed medication orders, other pertinent parameters in Pharmacokinetic dosing, monitoring antibiotics, anti-coagulation, cardiac regimens Oversaw and boosted productivity of 4 pharmacy technicians by training on IV and sterile-compounding techniques/ delivery (USP 795, 797, 800), and drug inventory control. Reviewed chemotherapy protocols, and created care guidelines, and utilized radiation/oncology electronic medical record system to assist with chemotherapy regimen selection, management, and monitoring; reviewed published data, lab values, and concomitant disease states to manage medication orders and dosages for appropriateness of chemotherapy regimens, and concomitant disease states Monitored for drug interactions, MTM and response to treatments - pre-medications, and side effects Advised prescribers on recommended changes to chemotherapy and related orders; anticoagulation dosing and monitoring - conversion, management Optimized order evaluation through extensive review of medication order, recommend appropriateness and pharmacokinetic dosing of prescribed orders before entering, processing, and dispensing of medication ordersResearch / Investigational Pharmacist - National Institute of Aging (N.I.A.) - GHResources, Ply- mouth Meeting, PA Towson / Woodlawn, MD 40 hrs March 2008 - March 2011 Prepared and reviewed clinical and medical information for Grant Proposals, IRB reports, documentation - Human Subject Protection; oral and written presentations; Implemented Study Protocol per Study Design, FDA regulations and as Pharmacist applied relevant knowl- edge and pharmacotherapies consistent with clinical trial protocol; medication safety; SOP guidelines Liaising with Clinical Investigators, reviewed and implemented Clinical Trial per SOP in IND, NCE, etc Documented CTCAE and analyzed data & statistics onto excel, clinical trials and designs updates SLPs, for- mulary, optimize and provide appropriate clinical information on treatment, clinical pathways, access (to NTDs, INDs, Orphans Drugs/NDA), and FDA Compliance, and GCP, 12 CFR(E6) - 312, 314; 45 CFR 46 Clinical Pharmacist - Mt. Washington Pediatric Hosp, Baltimore, MD 40 Hrs May 2009 - May 2011 Reviewed, interpreted, monitored medication orders in acute/chronic care, antibiotic stewardship and pharmaco-kinetics.- Implemented and processed advanced knowledge of policy-making by participating in P&T Committee, gained understanding in operating units - internal medicine, critical care, infectious diseases, chronic care, HIV, and anti-coagulation- Assessed patient medication profiles and orders, dosing and appropriateness of therapies, and dis- pensed medications; counseled patients regarding dietary, and/or medications Intra-Ven. Infusion / Amb. Pharm. - Kaiser Towson / Woodlawn, MD 32 Hrs Sept. 2008 - March 2011 Pharmacist, Walgreens Pharmacy - Cleveland, OH; Baltimore, MD 40 hrs - Oct. 2009 Pharmacist Graduate - Walgreens Pharmacist, Cleveland, OH <16 hrs Sept. 2007 PRN Pharmacist Graduate - Cleveland Clinic, Cleveland, OH (40 hrs) June. 2007 - Dec. 2007 Reviewed chemotherapy protocols, and monitored for regimen appropriateness, accessing the radia- tion/ oncology electronic medical records to assist with appropriate chemotherapy management, and monitoring of side effects; reviewed for accuracy and appropriateness of medication orders through order review, clinical appropriateness - indications, dose, adverse events, contra-indications, and consistent with state and federal regulations Implemented USP 797/800 guidelines and skills in Chemotherapy and Infusion Pharmacy, and acute rehabilitation, and research Provided drug information to Research subjects, team, physicians - reviewed IRBs, Inclusion/ exclusion criteria in randomizing blindness into trial design Reconstituted drug regimens in aliquots - according to study protocol; IV compounding under USP 797 / 800BENCH & some CLINICAL RESEARCH EXPERIENCESSenior Research Assistant - Cell Works Inc., Johns Hopkins Univ., Balt, MD Dec. 1997 - August 2001 Reviewed clinical protocols, prepared case reports according to IRB, SOPs, ICH, GCP, FDA, and IOP guidelines Evaluated the uptake of NCE - chemotherapeutic agents at hepatocytes using radio-labeling, in situ hybridization and immunocytochemistry Analyzed drug delivery systems of thymidylate synthase pro-drugs using DNA, RNA, and protein extraction, and PCR identifying and analytic techniques Mastered tissue culture techniques using harvesting, fixing, sectioning and preservation techniques Achieved proper sterile procedures, instrumentation and animals for surgery Optimized literature search and evaluated clinical trials and data using Minitab and Excel Research Technician - National Institute of Drug Abuse (N.I.D.A), JHU., Balt., MD Dec. 1995 - Aug. 1997 Identified neurotrophic factors implicated in dopamine storage and transmission; mastered tissue culture techniques Mapped transmission pathways via enzyme release and transporter system, utilizing in-situ immunochemistry in brains of athymic mice Evaluated the uptake of chemotherapeutic pro-drug on hepatocytes using radio-labeling, in situ hybridization and immunocytochemistry Analyzed drug delivery systems of chemotherapeutic compounds using DNA, RNA, and protein extraction, and PCR Mastered tissue culture techniques using harvesting, fixing, sectioning and preserving techniques Achieved proper sterile procedures, instrumentation and animals for surgery Optimized and evaluated literature search and evaluated clinical trials, design and data using SAS, Minitab and Excel Managed lab personnel and procured inventorySenior Laboratory Technician, Dept. of Radiology and Nuclear Medicine, Univ. of MN Dec. 1995 - Dec.1997 Identified through optimized small organic compounds synthesis using HPLC techniques, quantitative analysis of vesamicol compounds and its analogues, and MIBT isomers Evaluated binding efficiency of vesamicol ligands to acetylcholine and dopamine receptors in neurodegenerative diseases - Alzheimers and Parkinson Diseases Optimized and mapped the areas implicated in rodents, utilizing synthesized small organic compounds to mimic MIBT isomers through HPLC techniques Optimized the mapping in brain cortex, cerebellum of rodents implicated in neurodegenerative diseases Synthesized small organic compounds using chemistry analytical techniques PROFESSIONAL ASSOCIATIONS- May 2008 - Present WMSHP Washington Metropolitan Society of Health-System Pharmacists- 2004 - Present ASHP American Society of Health-System Pharmacists- 2011 - Present MSHP Maryland Society of Health-System Pharmacists |
