Safety Officer Data Entry

Location:

Houston, TX

Posted:

May 07, 2023

Contact this candidate

Resume:

EDUCATION:

Villanova University

Villanova, Pennsylvania, Lean Six Sigma Black Belt

Certification Program, May 2012

Johns Hopkins University

Baltimore, Maryland, Masters Public Health, May 2011

Rutgers University

Piscataway, NJ, Post-Doctorial Fellowship, July 1996

University of Michigan Medical Center and College of Pharmacy

Ann Arbor, MI General Practice Residency, August 1995

Texas Southern University School of Pharmacy

Houston, TX Doctorate in Pharmacy, August 1994

Texas Southern University School of Pharmacy

Houston, TX B.S. Pharmacy, August 1986

LICENSURES / CERTIFICATIONS:

Texas Board of Pharmacy

EMPLOYMENT

Empire Pharmacy Consultants

Title: Pharmacist in Charge

Hire Date: March 2022 – Present

ESSENTIAL DUTIES AND RESPONSIBILITIES

Dispenses prescribed medications, drugs, and other pharmaceuticals for patient care by performing the following duties.

Reviews prescriptions issued by physician, or other authorized prescriber to assure accuracy and determine formulas and ingredients needed.

Compounds medications, using standard formulas and processes such as weighing, measuring, and mixing ingredients.

Directs pharmacy workers engaged in mixing, packaging, and labeling pharmaceuticals.

Answers questions and provides information to pharmacy customers on drug interactions, side effects, dosage, and storage of pharmaceuticals.

Maintains established procedures concerning quality assurance, security of controlled substances, and disposal of hazardous waste drugs.

Enters data such as patient name, prescribed medication, and cost, to maintain pharmacy files, charge system, and inventory.

Assays medications to determine identity, purity, and strength.

Instructs interns and other medical personnel on matters pertaining to pharmacy.

PASSIONATE HEART HOME CARE SERVICES, LLC.

Hire Date: April 10, 2016 – May 2022

Title: Owner - Clinical Drug Regimen Review Consultant/Administrator Home Care.

DUTIES/PRIMARY RESPONSIBILITIES

Drug Regimen Review

Client drug regimens are reviewed on a set schedule. Frequency determined at the time of initial contact.

The PharmD will discuss any irregularities with the client or the client’s representative who will discuss with their own physician.

PharmD with document drug regimen review within the client’s files.

Provide the client with current information pertaining to medications.

Provide training for new health care professionals

Participate in ongoing in-service training of staff.

Present specialized lectures or discussions in the area of medications as these needs arise to the Administrator, the Director of Nursing, or physicians as requested

Attend appropriate organization and facility meetings when.

Administrator Duties

Responsible for taking service inquiry calls from prospective clients and turning them into new client assessments for the CEO.

Responsible for all duties related to service inquiry calls including taking the initial Service Inquiry Calls, sending information to new prospects, following up with the prospects, setting new assessments, and inputting information in back-office software. Responsible for coordinating all scheduling activities with the Staff Coordinator and tracking these updates and changes in the scheduling system.

Oversight over all payroll duties. This includes making sure payroll is accurate, timely, and managed correctly. Oversight over all billing duties. This includes making sure billing is accurate, timely, and managed correctly. These duties include collections, accounts receivable, deposits, invoicing, billing correspondence with clients, and all other duties relating to billing.

Oversight over all interoffice purchases. This includes all office supplies and other items. Oversight and management of all new hire paperwork, employee files, and client files. Responsible for the maintenance and accuracy of the scheduling system. Oversight of all employee benefits, including supplemental and health benefits. Responsible for assisting the CEO in keeping all staff manuals and policy/procedure manuals up to date and accurate.

Responsible for reporting directly to the CEO on all the duties listed above on a weekly basis.

JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT

February 2008 – January 2016

Title: Director, Product Safety Evaluation, Therapeutic Area Lead

JOB DESCRIPTION

Author submissions and other regulatory documents to submit to Regulatory affairs to obtain approval for new or products.

Lead a team of Scientists who reviewed products and products considered devices through oral and written communication regarding pre-submissions strategy/ clarification and follow up of submissions under review.

Lead support of marketing, new product development and operations in regulatory assessment of proposed changes.

Lead team to interface with FDA and other regulatory agencies on submissions, and other safety issues.

Lead team to interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.

Lead team that prepared and updated US and international product labels.

Represent Drug Safety/Pharmacovigilance during FDA inspections or other government agency audits as required.

Direct, and supervise the Product Safety Evaluation staff and others within the assigned therapeutic area. Assign workflow as appropriate to assure compliance with timelines and performance management of staff. Oversee technical quality of output for preparation of the safety reports.

In collaboration with GMS Physician or designee, preparation, drafting and writing of ad-hoc regulatory and aggregate reports, labeling and related documents.

Strategically plan and ensure timely, quality reports/safety analyses related to core deliverables

Lead collaboration with TASH/MSO/PVP and other stakeholders on strategy development

Oversee search execution

Lead aggregate safety analysis and case level review

Author, contribute, and coordinate the preparation of core safety deliverables.

Assigned complex products and reports where coordination and leadership of multiple scientists is required

Ensure commitments (e.g., PVAs, assessment reports) are met

Partner with vendor to develop reports/deliverables.

Proactively support TA-related business

Provide SMT support to enable proactive safety management

Act as core member of SMT for assigned products

Responsible for product accountability by maintaining product intelligence (i.e., creating agendas and documenting decisions, milestones, action items in minutes)

Deliver innovative solutions for aggregate safety strategy and analyses

Training/Meetings/Audits/Inspections

Participate in cross-functional training of relevant stakeholders

Act as product or process SME during audits/inspections

Dept./cross-functional initiatives (10%)

Lead department and/or cross-functional initiatives

Evaluation of safety data for assigned products:

Case series review or review of tabulated data

Review of safety surveillance data including lot trend information for selected products

Initiate searches of post-marketing database and related pharmacovigilance sources such as but not limited to scientific literature, Health Authority databases, etc

Preparation of materials for use in development of regulatory documents such as Company Core Data Sheets, SmPC, etc.

JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT

March 2004 – February 2008

Title: Associate Director, Benefit Risk Scientist

JOB DESCRIPTION

Scientifically researches efficacy and safety issues of assigned products:oEvaluation of the safety profile of assigned drugs

oSupport proposed CCDS and major/global label changes

oResponses to regulatory (Health Authority) questions

oNew safety informationoWriting key documents (narrative summaries, expert reports) that summarize new safety data

oDevelops and periodically updates the core documents (FS, PC, BRAR)

o•Provides global medical support for benefit-risk questions (marketed drugs which have no CDT)o•This function works closely with other physicians/scientist such as MAPs, surveillance, and epidemiology

AVENTIS PHARMACUETICALS INC.

September 1997 – March 2004

Title: Associate Director, Product Safety Officer

Role:

1.Clinical evaluator/reviewer for all adverse event reports for assigned products.

2.GSO support for PSUR/SER production, signal detection/analysis.

Responsibilities:

1.Review: all individual adverse event reports for clinical and regulatory assessment. Clinical: assesses cases for clinical implication, enters case evaluation comment into ClinTrace, directs follow-up for serious adverse events with relevant units. Initial medical assessment of spontaneous and clinical trial cases for one or more drugs, investigation of reported adverse events and ensuring case related procedures are followed according to global SOPs, supervision of medical data entry staff following the principles of HMR User Manual, providing medical advice, participation in signal handling and assistance in preparation of safety documentation, reporting to local authorities: checking all received cases (global and local) for reporting requirements, selecting those which require reporting and adding local information. Involved with coding team and MedDra.

2.Serves as study team safety manager for assigned NA Regional study teams, including study protocol review/input, database reconciliation for serious adverse event data between ClinTrace and clinical study database in cooperation with study team, provides input into safety analysis section of all relevant study documents (ie. study report), review of final study report. Contributes and communicates in an ongoing manner regarding product risk assessment for assigned studies to the local study team and the Global Safety Officer/global project team. Contributes to investigator and monitor training regarding reporting/ processing of study safety information/adverse events

3.May serve as local safety officer for assigned products marketed in the US.

4.Performs signal detection/analysis activities under direction of Global Safety Officer/ TA Head

5.Provides support to Global Safety Officer for production of documents required for global dossier/ product approval (ie. integrated safety summary)

6.Maintain clinical knowledge in assigned therapeutic areas, and knowledge of US regulations

Accountabilities:

1.Internal: Global Head of GPE, GPE Therapeutic Area Head, GPE Head of Clinical Safety Analysis, GPE Head of Standards and training, legal, NA Regional clinical development project leaders and clinical managers.

2.External: Regulatory authorities, Ethics committees, Patients and Prescribers.

Authorities:

1.Ensure timely, appropriate and consistent single medical case assessment and follow-up, including company clinical/regulatory assessment and clinical evaluator’s comment

2.Ensure timely completion and medically sound conclusions of safety sections of study reports.

3.Identify and discuss safety issues internally, assist internal safety analysis and production of relevant documents (ie. PSURs, SERs

4.Communicate internally agreed upon safety measures with affiliates, study teams, and external bodies/authorities /DSMBs.

5.Ensure that SOPs for safety data handling are followed in assigned post-marketing and development projects

Bristol-Myers Squibb U.S. Pharmaceuticals

Princeton, NJ

Medical Liaison (Medical Services Manager)

July 1996 - September 1997

Duties and responsibilities include: Interfacing with field operations in the identification of high potential physician/opinion leaders; Calling upon them and establishing rapport; Assessing suitability of physicians to conduct Phase IIIB/IV/ V studies; Layout the groundwork for future product launches; Providing medical /scientific information and literature for physician/pharmacist education; Involvement with local medical education (symposia, program development).

Rutgers University/Bristol-Myers Squibb Company

Princeton, NJ

Post-Doctorial Industry Fellowship-Professional Services

August 1995 - June 1996

Duties and responsibilities include: Preparing medically accurate and strategically appropriate verbal and written responses to customers requests regarding BMSUSP product information in the metabolic, cardiovascular, anti-infective and CNS areas; providing timely surveillance of the medical literature to assure that key data are maintained within the standard response databases; managing the medical information system (journals, texts, files) to assure immediate availability to key literature citations; providing support for Customer Marketing, Medical Service Managers, and Sales Representatives; developing letters and presentations for customers in support of key campaigns; providing support through medical presentations and sales training; in addition to disease state management initiatives.

Clinical Instructor

Rutgers University College of Pharmacy

Piscataway, NJ

University of Michigan Medical Center and College of Pharmacy

Ann Arbor, MI

Pharmacy Practice Residency (ASHP Accredited Residency)

September 1994 - August 1995

Target Drug Program

Parenteral and Enteral Nutrition

Infectious Disease

Internal Medicine

Critical Care Medicine

Anticoagulation Clinic

Critical Care Medicine

Pharmacy Administration

Drug Information

Industry (Bristol-Myers Squibb Company)

Clinical Instructor

University of Michigan Medical Center and College of Pharmacy

Ann Arbor, MI

The Methodist Hospital - Houston, TX

November 1989 - August 1994

Staff Pharmacist, duties and responsibilities include coordinating the appropriate monitoring and dispensing of all drugs to patients in the Hospital. This includes IV preparation, TPN's, Chemotherapy, extemporaneous compounding and IV Minibags; monitoring patient charts and profiles for appropriate drug use, including screening for and reporting drug interactions and adverse reactions; supporting the formulary

System and assisting in maintaining cost effective drug use; recommending formulary products when non-formulary drugs are prescribed; participation in the education and training of other pharmacists, technical staff, students and other health professionals; Supervision of technical staff; managing daily workload fluctuation with respect to staffing and assignment. Collecting productivity data; documenting all clinical interventions; providing drug therapy information and drug consults to physicians and nurses; communicating verbally and in writing with medical, nursing and other health care professionals.

Walgreen's Drugs - Houston, TX

April 1989 - November 1989

Management of Drug Department, duties involved assuring that gross profit of store meets company standards, reviewing and filling prescriptions via computer, ordering products and inventory control.

Eckerd's - Houston, TX

October 4, 1986 - April 1989

Pharmacist Manager, duties include management of the OTC and prescription drug departments. This involved assuring that gross profit for the store meets company standards, reviewing and filling prescriptions via computer, supervising the order and inventory control of OTC and Rx drug departments. Duties included recruiting, training and management of employees.

CURRENT PROFESSIONAL AFFILIATIONS

Drug Information Association

PUBLICATIONS

Tacrolimus: a new agent for the prevention of graft-versus-host disease in hematopoietic stem cell transplant; Bone Marrow Transplant 1998 Aug; 22(3):217-25.

PROFESSIONAL PRESENTATIONS

Tacrolimus In Bone Marrow Transplant

University of Michigan Medical Center

Department of Pharmacy Services

April 14, 1995

Sumatriptan In Migraine Headaches: A Case Presentation

University of Michigan Medical Center

Department of Pharmacy Services

January 30, 1995

Evaluation of Guidelines for the Use of Neuromuscular Blockers, Analgesics and Sedative Hypnotics in the Critical Care Medicine Unit

University of Michigan Medical Center

Department of Pharmacy Services

November 28, 1994

Clinical Use of Survanta in the Management of Respiratory Distress Syndrome