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Roy Brisendine II, BSRN, MBA

523 Lexington Ave.

Chalfont, PA 18914
* Drug Safety \ Pharmacovigilance:
Safety Data Exchange Agreement (SDEA) Specialist
Familiarity with ARGUS, TrackWise, ARISg, NWAES & DEIOS
Risk Management Program (RMP), RiskMAP, REMS a" Safety Lead
Serious Adverse Event reporting (FDA 21 CFR), and Reconciliation Expert
* Clinical Operations & Strategic Improvements:
Re-engineering of Hospital operations & deficiency remediation
* Continuous Process Improvement of Quality Indicators, & Training
Director of 3-Clinical departments with >100 FTE direct reports
* Motivation & Retention program eliminating contract labor costs
* Marketing & Business Management:
Marketing Analysis, Strategic Implementation, and Business Plan Lead
B2B, Direct mail, Direct to consumer, and Radio advertising
Business expansion, Brand development, Market penetration
Drug Safety Associate, Teva Pharmaceuticals USA, Inc, Horsham, PA
(September 2007 a" Present)
* Adverse event & Serious adverse event reporting FDA 21CFR
* Safety Data Exchange Agreement (SDEA), Specialist-Project Leader
* Project manager for SOP annual competency training
* Quality Assurance & Pharmacovigilance reconciliation, Project Manager
* Risk Management Program & Opioid REMS, Project Lead
Manager, Drug Safety, Alliance Healthcare Information Ivyland, PA
(March 2007 a" August 2007)
* Managed 7-Drug Safety Associates for Safety Reporting.
* Quality Control Lead for Adverse Event (AE) Reporting.
* Management of Drug Safety Reporting Systems (Argus, TrackWise).
* Managed AE reporting for multiple pharmaceutical companies.
* Statistical data analysis, trend analysis, quality control reporting.
* Productivity analysis, performance improvement, motivation & retention.
Adverse Event Reporting\Drug Safety Specialist, (Contract) Merck, Blue Bell, PA
(April 2006 a" March 2007)
* Adverse event data management a" NWAES (New Worldwide AE system)
* Knowledge of FDA 21 CFR regarding adverse event reporting
* Familiarity with NDA\INDA a" SOPs for the reporting of adverse events
* Adverse event & Serious adverse event reporting using FDA 3500 & E2B
* Training in: MedDRA terminology, AE\SAE reporting, DEIOS, & NWAES
Clinical Research Nurse, MedSource Pros (Contract) Glaxo Smith Kline, Phila., PA
(September 2004-December 2004)
* Phase I - IV clinical trials
* Informed consent, Clinical Report Forms, Data Cleaning
* SOPas, Data collect, and Adverse Event Reporting
RN-Intensive Care Unit\Interventional Radiology\PACU\SPU,
Central Montgomery Medical Center, Lansdale, PA
(September 2004a"April 2006)
Frankford Hospitals, Langhorne, PA
(June 1999 a" May 2002)
Nurse Manager, Kindred Hospital, Philadelphia, PA
(February 2004 a" August 2004)
* Manage: 3 nursing supervisors & 99 FTEas, Acuity based staffing ratios
* Recruit & hire new Nursing staff a" eliminating contract labor ($1MM annual)
* JCAHO & DOH regulations, Policies & Procedures, Budgeted HPPD
Director of Clinical Services, Select Specialty Hospital, Philadelphia, PA
(February 2003 a" February 2004)
* Responsible for daily clinical operations, reporting directly to the CEO.
* Develops and implements Business strategies for clinical operations.
* Manages: Nursing, Rehab, & Respiratory areas, Staff Development, & QAPI.
* Ensures clinical Policies\Procedures comply with State\Federal regulations.
Owner - President, Relaxations Day Spa, Yardley, PA
(January 1996 a" September 2004)
* Marketing strategy including: penetration, branding, & extension.
* Doubled sales by expanding business into 2 new markets.
* Increased market penetration by opening new locations.
MBA in Business Management, LaSalle University
GPA: 3.7 a" May, 2007 (Magna cum Laude)
Masteras Certification in Project Management, Villanova University (PMP Pending)
Lean Six Sigma Green Belt, Villanova University (Black Belt in progress)
BS in Healthcare Services Management, Philadelphia University
GPA: 3.75 a" May, 2002 (Magna cum Laude)
ADN a" Registered Nurse, Bucks County Community College
GPA: 3.8 a"June, 1999 (Phi Theta Kappa)
U.S. Senate Resolution awarded for exemplary and meritorious work in the fields
of Healthcare and Community Service (2000 - 2001).
Founder/Volunteer Acting President - Into Action Childrenas Charity
* Responsible for securing corporate sponsorship, Fund raising, networking with
area physicians and healthcare providers.
Phi Theta Kappa, National Honors Society, President BC3 Student Nurses Associati