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Manager Medical

Location:
Philadelphia, PA, 19130
Posted:
March 09, 2010

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Resume:

Bryon Martin Pearsall

Registered Patent Attorney and Pharmacist

*** *. ***** ******, ************, PA 19130

215-***-**** abm6lj@r.postjobfree.com

____________________________________________________________________________

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EDUCATION

Juris Doctorate, with Honors (2005) Widener Law School, Wilmington, DE

Cum Laude, GPA of 3.25, Health Law Certificate with Honors; Focus on

Intellectual Property, Patents, and Health Law; and Intellectual Property

Society Founding Treasurer.

Bachelor of Pharmacy (1995) University of the Sciences, Philadelphia,

PA

LICENSURE

Registered Patent Attorney (2008)

Registered Attorney (2005) PA Supreme Court; US District Court,

Eastern District of PA; and NJ District Court

Registered Pharmacist (1995) Pennsylvania and Delaware

SKILLS

. Litigation Experience: Attend depositions and settlement conferences.

Prepare a variety of legal documents including briefs, memos, complaints,

interrogatories, requests for documents, affidavits, notice of

depositions, depositions, and correspondence to clients and opposing

counsel. Research and analyze a variety of legal issues involving medical

malpractice, mold, auto accident, slip and fall, and insurance defense.

. Patent/Intellectual Property: Course work including: patents, patent

practice, copyrights, trademarks and unfair trade practices, and PLI

patent review.

. Regulatory Experience: Over ten years of pharmacovigilance experience.

Prepare periodic safety utilization review documents. Review adverse

event reports for direct report team consisting of up to 10 members.

Prepare and review worldwide literature, study and spontaneous event

reports. Experience with VAERs and medical device reports. Assist with

audit and compliance preparation. Review scientific literature for

assigned products. Review labeling changes for assigned products.

Database reconciliation, validation of in-house adverse event reporting

system, and coding review. Working knowledge of US and international

pharmacovigilance regulations and guidance documents.

. Project Management: Develop, review & implement processes to improve

efficiency, including a process to create adverse event reports for

business partners, a procedure for obtaining clarifications from other

departments, and procedures for handling issues experienced at external

sites.

. Employee Management: Manage and problem-solve issues for external

contract agencies (over 250 employees). Manage workload for document

reviewers ensuring all documents are reviewed within regulatory deadlines

(over 30 employees). Directly manage document reviewers and report

writers (up to 20 employees).

. Training: Train team leads on legal clarification methods to improve

quality of clarifications. Train team leads on problem solving skills to

assist in responding to problems and issues that occur at external

affiliate sites. Train new hires on appropriate safety data reporting and

in-house reporting systems.

. Inter-departmental Interaction: Prepare detailed written responses to

information requests from medical monitors, the legal department, and a

variety of other departments. Primary liaison between safety employees

and document triage staff. Assist in writing sections of regulatory

documents for the regulatory department and the clinical research and

development department.

. Standard Operating Procedures: Serve as second chair for the guideline

and standard operating procedure committee; team responsible for writing

and reviewing departmental standard operating procedures.

. Accomplishments: Prepared a comprehensive report on the in PA medical

malpractice litigation based on the MCARE Act and the PA Rules of Civil

Procedure. Earned superior ratings on annual performance evaluations,

recognized by rewards and recognition committee for outstanding

achievements, accolades for superior writing skills, and recognized for

accurate and efficient processing by team leader.

EMPLOYMENT

02-2006 - Present Vioxx Drug Safety Team Lead, Merck, Inc. (K-Force),

Blue Bell, PA

07-2005 - 02-2006 Associate Attorney, White and Williams, LLP, Berwyn,

PA

06-1999 - 07-2005 Drug Surveillance Manager, Wyeth Research,

Collegeville, PA

12-1996 - 06-1999 Pharmacy Team Leader, CVS Pharmacy, Philadelphia, PA

12-1995 - 10-1996 Assistant Pharmacy Manager, Wal-Mart Pharmacy,

Milford, DE

05-1995 - 12-1995 Staff Pharmacist/Pharmacy Intern, Thrift Drug,

Rehoboth Beach, DE



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