DONNA M. DUMONT, RPh.

Greenwood Lake, NY 973-***-**** / ad4oqe@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Practicing pharmacist for over 20 years with extensive experience in hospital, retail, home infusion, and pharmaceutical industry settings

Knowledge of TPN, chemotherapy, and other intravenous admixture compounding

Eight years of Pharmaceutical Industry experience in Drug Safety and Pharmacovigilance

Extensive knowledge in the processing of Individual Case Safety Reports (ICSR).

Policy/Procedure Development

Customer Service, Call Center

Management of personnel

KEY SKILLS

Experience with electronic safety databases including ARISg, Argus, Clintrace.

Experience in Triage of incoming reports, Coding, Labeling, Narrative writing, Adverse Events Reporting, review of source documents, medical records and literature documents.

Experience with coding dictionaries, such as MedDRA and the WHO Drug dictionaries.

Computer skills: MS Office Suite: Word/Excel/Power Point/MS Access and electronic document management systems.

PROFESSIONAL EXPERIENCE

National Agent Alliance (NAA) Jan 2015-present

Licensed Agent

Specializing in Term/Whole Life insurance, Mortgage Protection insurance, Final Expenses, Annuities.

Assist clients (individuals, families, and businesses) choose insurance policies by explaining the different coverages available to them, and making recommendations that suit their needs.

Help policy holders settle insurance claims.

Contact potential and existing clients to set up appointments, take care of any unfilled claims, and to make sure NAA is satisfying their needs as a customer.

Seek out new clients.

Transamerica (World Financial Group), Fairfield, NJ Mar 2013-present Registered Representative

Develop custom strategies to help clients reach their financial goals and objectives.

Helping individuals and families plan for their financial future.

Help clients earn money, save money, reduce taxes an get out of debt.

Help individuals and families achieve financial independence.

Boehringer-Ingelheim, Ridgefield, CT Dec 2012-Mar 2013

Triage Manager I (Contractor)

Identify any missing medical data in both spontaneous and clinical trial cases.

Raise queries to request additional medical information.

Highlighting of hospital discharge letters, autopsy reports and lab reports.

MedDRA coding of all events for spontaneous cases.

Assist with collection, processing, and reporting on adverse event reports.

Scientific review of all sources, including literature, to review adverse event

Information, accuracy of case narratives and suspect drug entries.

Reconciliation of insufficient timelines for BI and licensed partners cases.

Sentrx, Little Falls, NJ Mar 2012-Dec 2012

Quality Reviewer (Temporary)

A member of the Special Projects team participating in data migration projects.

Quality control review of adverse event reports for data inconsistencies, missing data, causality, expectedness, outcome and the narrative.

Provide support to the Data Entry Specialists and Data Entry Coordinator.

Adhere to client specifications while ensuring regulatory compliance.

Meet specific project objectives, including data quality, volume and timelines.

Ability to handle high case volume of complex cases as needed.

Answers health care professionals and patients questions concerning various products in a call center environment.

Otsuka Pharmaceutical, Rockville, MD Oct 2011-Mar 2012

Drug Safety Associate (Contractor – Maternity Leave coverage)

Review clinical study adverse events for accuracy, integrity and consistency according to project specific guidelines, as reported on Immediately Reportable Event forms for the oncology product, Busulfex.

Data entry, review, QC and preparation of queries in Argus of clinical trial cases.

Prepare narratives, according to approved template.

Call physicians in order to collect information regarding adverse events associated with Samsca.

Review literature articles and perform literature searches using the Virtual Library as needed.

Submission of 15 day reports for serious, related and unlisted Pletal cases to Regulatory.

Perform triage and assign priority to incoming events.

Interact with project team members to ensure correct and timely adverse event processing.

Adhere to required timelines for completion of adverse event reports.

Patni Life Sciences / Sanofi Aventis, Bridgewater, NJ Jul 2009-Oct 2011

Senior Drug Safety Specialist (Contractor)

Enter international and domestic adverse events data from spontaneous sources.

Utilize MedDRA dictionary to code adverse events and medical history.

Prepare clear and concise narratives of the events.

Identify clinically significant information missing from initial reports and facilitate its collection.

Make necessary corrections as per regular Quality Control queries.

Review and correct electronic case reports following entry.

Review all adverse event reports from reports for completeness and consistency.

Participate in case management team meetings and projects.

Our Lady of Mercy Medical Center, Bronx, NY Jul 2006-Jun 2007

Clinical Pharmacist

Extensive IV infusion compounding.

Clinical order verification in both the in-patient and out-patient pharmacy departments.

Provided in-services for the pharmacy staff.

Novartis Consumer Health, Parsippany, NJ

Drug Safety Scientist II Jun 2007-Jul 2009

Drug Safety Scientist (Contract-to-Hire) Nov 2005-Jul 2006

Perform daily responsibilities in accordance with all applicable Standard Operating Procedures (SOPs), conventions and company policies.

Collect, document and process adverse event reports from marketing activities, including non-serious and serious events, and formulate follow-up needs.

Aggregate report preparation.

Communicate changes to affiliates regarding case upgrades (non-serious to serious).

Perform triage of incoming AE reports (including literature cases) for completeness, consistency and seriousness; prioritize per regulatory and company guidelines (includes reviewing and medically evaluating relevant drug safety information and alerting Medical Surveillance Experts (MSEs) of potential serious case assessments and/or case trends).

Generate and track requests for follow-up information.

Inform Case Processing and Quality, Training & Compliance groups of late cases.

Perform duplicate check and book-in manual cases as backup to Drug Safety Associates (DSAs) if necessary.

Perform Quality Control reviews of cases and communicate recommendations to processors.

Ongoing mentorship/training to entry level Drug Safety Scientists (DSS).

Communicate changes to affiliates regarding case upgrades (non-serious to serious).

Support literature searches for medical inquiries and process assigned cases.

Identify critical missing information and consult with MSEs as required.

Communicate with foreign affiliates regarding safety issues.

Independently prepare and data enter narrative summaries for adverse event reports from spontaneous post-marketing surveillance.

Prepare and process expedited MedWatch and CIOMS adverse events reports.

Perform all duties of DSS I as required.

Medical review of legal cases.

Answers health care professionals and patients questions concerning various products in a call center environment.

Pfizer Pharmaceuticals, Morris Plains, NJ Apr 2005-Nov 2005

Drug Safety Associate (Contractor)

Collect, document and process adverse event reports from marketing activities, including non-serious and serious events, and formulate follow-up needs.

Perform duplicate check and book-in manual cases as backup to Drug Safety Associates (DSAs) if necessary.

Communicate changes to affiliates regarding case upgrades (non-serious to serious).

Identify critical missing information and consult with MSEs as required.

Communicate with foreign affiliates regarding safety issue.

Independently prepare and data enter narrative summaries for adverse event reports from spontaneous post-marketing surveillance.

Prepare and process expedited MedWatch and CIOMS adverse events reports

Perform active follow-up via telephone contact with consumers and health care professionals.

Answers health care professionals and patients questions concerning various products in a call center environment.

ADDITIONAL WORK EXPERIENCE

Deal Pharmacy, Deal, NJ 1998-2005

Pharmacy Manager

Managed all aspects of a pharmacy’s daily operations. Processed and dispensed medication according to physician directives. Purchased supplies and conducted regular counts of inventory.

Dispensed approximately 250 prescriptions each day, consistently achieving accuracy and efficiency ratings of greater than 95%.

Compounding.

Review, interpret, and accurately dispense prescribed medications.

Assist in the training and development of pharmacy department personnel.

Provided patients and their families as well as healthcare professionals with counseling on legend, OTC, and alternative medicine as well as natural products such as herbs and vitamins. Operated and maintained a Script Pro 200. automated dispensing machine, troubleshooting any operational problems.

Direct Script Inc., Edison, NJ 1994-1998

Pharmacy Manager

Start-up mail order pharmacy for Oxford Insurance members.

Review, interpret, and accurately dispense prescribed medications.

Assist in the training and development of pharmacy department personnel.

Review, interpret, and accurately dispense prescribed medications.

Developed and taught a pharmacy technician training course.

Homedco Infusion, Ridgewood, NY 1991-1994

Clinical Pharmacist / Pharmacy Manager

Prepared chemotherapy, TPN, and intravenous solutions as well as IV admixtures; procured and prepared investigational drugs.

Significantly reduced errors and waste for Homedco Infusion by creating a supply sheet that simplified the type and amount of supplies required for specific home infusion nursing procedures.

Assisted in the training and development of pharmacy department personnel.

Created a cost effective tool for supply and inventory cost reduction in the pharmacy and nursing departments.

Saint Barnabas Hospital, Bronx, NY 1990-1991

Staff Pharmacist, Night Shift

Clinical order verification.

Compounding.

Review, interpret, and accurately dispense prescribed medications.

Response to drug information questions.

Co-authored a monthly pharmacy newsletter circulated throughout the hospital.

Montefiore Medical Center, Bronx, NY 1989-1990

Staff Pharmacist

Clinical order verification.

Compounding.

Review, interpret, and accurately dispense prescribed medications.

Manager of pharmacy satellite.

Montefiore Medical Center, Bronx, NY 1988-1989

ASHP accredited PGY1 Clinical/Administrative Pharmacy Residency

EDUCATION /TRAINING

Pharmacy Technician - United States Air Force, Sheppard AFB, Wichita Falls, TX

5-year Bachelor of Science in Pharmacy - St. John's University

LICENSURE & CERTIFICATIONS

APhA’s Pharmacy-Based Immunization Delivery certificate

Licensed Pharmacist (#033-*******), Vermont State Board of Pharmacy

Certificate, Pharmacy Technician, Community College of the Air Force

Accident and Health Producer License (LA-1308408)

Life Producer License (LA-1308408)

Outdoor Emergency Care Certification

AFFILIATIONS

Member, American Pharmacists Association

Member, American Society of Health-System Pharmacists

Member, Pharmacists Society of the State of New York

Member, Advisory Board, Allied Medical & Technical Institute, Wayne, NJ

Trainer and coxswain at East Arm Rowing Club, Greenwood Lake, NY

Member, National Ski Patrol (# 223212)

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