Experienced Medical Information Manager with over 11 years of experience in the pharmaceutical industry. Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits.
Skills
Able to prioritize and organize
Ability to work independently and part of a team
Strong interpersonal skills
Work History
MEDICAL INFORMATION MANAGER, 09/2013 to Current Arena Pharmaceuticals – Morrisville, NC,
Oversees medical information (MI) for marketed drug products, including responding to product
inquiries, processing product complaints, and reporting adverse events.
Provides project management oversight to multiple clients to both internal staff members and client.
Provides training to staff members pertaining to system organ class and client products.
Manage the work of MI team members including process flow and QC, providing feedback as
needed.
Performs yearly reviews with direct reports providing and receiving feedback about the year.
Mentors and acts as a resource to new/junior staff and team members, meeting with team
members weekly.
Provides detailed training for incoming MI associates.
Handles escalated calls for difficult reporters.
Develops procedures for MI and safety surveillance activities, ensuring compliance with applicable
SOPs, ICH guidance, and Good Medical Information Practices.
Strong understanding of and ability to follow the FDA/ ICH requirements and Good Pharmacovigilance
Practices (GVP) and standard Medical Information Practices for AE reporting, complaints and inquiries
received.
Responsible for initial intake and triage of reports via telephone, email, fax and social media for MI, and
ensuring all AE reports received MI are routed to the pharmacovigilance (PV) Department for processing.
Appropriately manage call in-take and follow-up.
Ensures that all adverse event reports are assessed for reportability and that safety data is critically
evaluated, alerting pharmacovigilance personnel as necessary for specific projects/products.
Ensures all reporting timelines are met according the FDA/ ICH requirements, client procedures and
SOPs.
Collaborates with Database manager for MI database updates to meet client specifications as well as
streamline process flow.
Performs monthly key performance indicators as required by standard operating procedures.
Provides patient education on the phone to consumers about the use of pharmaceutical products or
devices according to approved label information.
Maintains trackers and provides input to develop project or individual metrics and works to balance
time, cost and quality for MI functional area.
Provides upper management concise reports of issues, progress or team activities.
Resolves questions around cases/calls, etc.
That may deviate from standard processing.
Knowledgeable in literature review processes utilizing PubMed with required search indicators,
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systematically reviews product-specific literature reviews to rule out or validate AEs.
Prepares and review medical information line listings and reconciliation reports for internal review for
accuracy, metrics, and quality control.
Participates in the development and review of PV-related regulatory agency reports that need metrics
from MI (which may include but is not limited to PADERS, CSRs, PSURs, DSURs, annual reports).
Collaborates with business development team to understand potential client needs, writing proposals
and providing presentations of MI capabilities.
MEDICAL INFORMATION ASSOCIATE, 03/2008 to 09/2013 Covance – Naples, FL,
Responsible for initial intake and triage of reports (primarily via telephone) for MI (including taking
messages or routing calls as needed) and ensuring all AE reports received MI are routed to the
pharmacovigilance (PV) Department for processing.
Documents all actions in detailed, clear and
objective telephone reports and/or memos.
Recognized reports of AEs while speaking with consumers and healthcare professionals calling with
inquiries or to report product complaints.
Performed data entry, case tracking, and overall case management of inquiries, product complaints, and
AEs; and, report product complaints to clients in accordance with procedures.
Followed up on inquiries, product complaints, and adverse event reports as required, or as directed by
the Project Manager.
Documented all actions in detailed, clear and objective telephone reports and/or memos.
Assisted with a major product recall.
CARDIAC TECHNICHIAN, 01/1998 to 01/2008 Tolman Clinical Labs – City, STATE,
Received and edited EKG's from patients over the telephone via a transtelephonic event monitor.
Scanned and edited 24-hour holter monitor tapes.
Troubleshoot computer systems and software for both types of monitoring.
Notified physicians of any abnormal findings, calling EMS if patients need to be transported to the
hospital.
Assisted the Lab Director with daily responsibilities, including providing support and troubleshooting for
physicians' offices, taking calls and complaints from both patients and offices, providing back up in all
areas of the cardiac lab including lab support.
MEDICAL ASSISTANT, Medical Assistant, 01/1994 to 01/2003 UMASS Memorial Medical Group – City, STATE,
For 5 physicians.
Answer office phones and schedule appointments.
Greet patients and prepare them for examinations.
Obtain patient medical history and vital signs.
Assist physician during patient examinations.
Perform routine laboratory tests and administer injections.
Explain treatment procedures, medications, special diets, or doctor's instructions.
Perform electrocardiograms or other diagnostic tests.
Authorize drug refills and provide prescription information to pharmacies.
Education
LPN Certificate Program: , Expected in 2004 Massachusetts Bay Community College - Framingham, MA GPA:
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