SUMMARY OF QUALIFICATIONS:
. *+ years of Medical Affairs experience in the Pharmaceutical
Industry, including 6+ years of Medical Information and 3 years in
Pharmacovigilance.
. Excellent writing skills with expertise in writing medical
narratives, narratives for periodic adverse drug experience reports
(PADER), drug safety conventions and company authored standard
response documents.
. Recipient of Stellar Performer Award for Drug Utilization Review
(DUR) at Medco Health Solutions (MHS).
. Responsible for DUR proposal that resulted in multi million dollar
cost savings for company.
PROFESSIONAL EXPERIENCE
SANOFI
Bridgewater, NJ
Manager, Medical Information Operations
January 2012 to present
Roles and Responsibilities
. Responsible for oversight of the Medical Information Outsourced
Center (MIOC) through utilization of technology tools, regular
and ad hoc communications.
. Manage the written dissemination of general product information
correspondence to both external customers and internal customers
utilizing accurate, complete, and fair balanced evidence based
information.
. Participate in the management of research and literature
evaluation and preparation of standard documents for use in
addressing Medical inquiries.
. Responsible for handling escalated inquiries and assuring that
training is regularly provided to the MIOC.
. Assist the Medical Information Services Head as necessary in
managing reports and providing an opportunity for growth and
development.
. Provides tactical implementation of strategic plans within MIS
and ensures that all activities are conducted within an optimal
regulatory framework.
. Develop relationships with other departments within Medical
Affairs.
Associate Safety Specialist, US Drug Safety September 2008
to December 2011
Roles and Responsibilities
. Responsible for identifying clinically significant information
missing from initial reports and facilitates its collection.
. Summarize the information in a clear and concise narrative for data
entry.
. Enter domestic adverse event data (from both spontaneous and
clinical trial reports) utilizing controlled vocabularies coding
(currently: MedDRA).
. Subject matter expert for Cardiovascular and Internal Medicine
products.
. Assist in aggregate report preparation for Periodic Adverse Drug
Experience Reports by preparing narratives, demonstrating best
practices.
. Maintain comprehensive, safety knowledge of assigned products
through review of global aggregate safety reports and review of
scientific literature.
Medical Information Specialist- US Drug Safety June 2005
to September 2008
Roles and Responsibilities
. Possess scientific knowledge focus on company products and related
therapeutic areas
. Provide evidence based information from clinical trials, published
medical literature and FDA approved product labeling to Health Care
Professionals and Consumers on a timely basis
. Identify and report adverse events
. Utilize standardized responses in providing response to inquiries
. Develop and maintain ongoing relationships with Medical Affairs
functions, through appropriate familiarity with current literature,
attendance at meetings and professional relationships.
MEDPOINTE PHARMACEUTICALS, Somerset, NJ
Manager, Medical Communications
Feb 2005 to April 2005
Roles and Responsibilities
. Respond to medical inquiries from external and internal customers.
. Develop verbal, electronic and written responses to healthcare
professionals and consumer inquiries as needed.
. Implement programs to leverage customer contact towards improving
business.
MEDCO HEALTH SOLUTIONS
Parsippany, NJ
Registered Pharmacist
October 1999 to August 2004
Roles and Responsibilities
. Perform Drug Utilization Review (DUR), Seniors DUR of patient cases as
well as presentation of analytical Retro Drug Utilization Review
reports.
. Responsible for Order Completion of fax and mail in prescriptions and
performing doctor calls of the same.
. Certified In-House Trainer
SKILLSET
. Experience using Siebel, Documentum, Clintrace, AWARE, Clint, COGNOS.
EDUCATION
Rutgers College of Pharmacy: Bachelor's of Science Degree in Pharmacy, May
1993
Shenandoah University: Doctor of Pharmacy (PharmD), December 2010.
PROFESSIONAL AFFILIATION
. American Pharmacists Association (APhA)