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Pedro S. Dinglasan, M.D.#2 Arrow DriveLivingston, New Jersey,
07039Tel.#: 973-716-0703 Cell#: 973-368-5229
RELEVANT ACCOMPLISHMENTS* Expanding role in pharmacovigilance
from single case medical review to includesignal evaluation and
PSUR, ASR and QSR production.* Contributed to the development of
ongoing safety monitoring plans* Contributed to the development of
SOP associated with pharmacovigilance activities.* Phase III
clinical trial experience to include protocol review and the
reviewof completed case report forms.* Past clinical trial internal
auditing case documentation and compliance as related to oncology
studies (ECOG)* Practical medical experience of more than 20 years
as a Consultant in Urology* Competency in MedDRA coding and triage
of serious reports base upon regulatoryguidance of serious
criteria* Multiple therapeutic product responsibilities of both
clinical and post-marketing events including oncology, hepatology,
respiratory, CNS and cardiovascular* Cross-trained in safety
databases including Oracle-AERS, Roche Advent System,and Argus
EMPLOYMENT HISTORY
11Sept2007 - 30Jun2010 Merck (Schering-Plough), Springfield, New
Jersey, USAAssociate Director, Global Pharmacovigilance MSCRM
* Single case medical review including medical evaluation and
CIOMS II commentsas related to causal relationship and alternative
etiology* Generate follow-up queries as related to complete medical
analysis for a specific event* Established as an authority for
triage and case processing to align safety follow-up with specific
events of interest and targeted questionnaires* Generated signal
evaluation for presentation to the Safety Review Board utiliz
ing historical safety information provided in PT summary reports
delineated by system Organ Class (SOC).* Identify SUSAR, Death and
or life threatening cases and submit them on timelymanner* Evaluate
all serious reports for potential signals that may require a change
to the existing safety profile of the product.* Review quarterly
line listings with signal specialist to identify any potential
safety risks* Literature review for potential cases* Preparation of
PSUR's sections VII through IX
Pedro S. Dinglasan, M.D.#2 Arrow DriveLivingston, New Jersey,
07039Tel.#: 973-716-0703 Cell#: 973-368-5229
22Jun2007 to 10Sept2007 Ranbaxy, Inc.
Medical Review Officer Drug Safety & Pharmacovigilance
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alist Hospital at Boca Raton, Florida.* Participated in the
development of audit procedures for proper
implementation,documentation and conduct of NYU study protocols.*
Review of IRESSA safety reports for completeness as related to
auditing responsibilities.* Supervisory role in project teams
concerning SAE safety issues as directed byNYU- IRB* Review and
edit Serious Adverse Events Report forms utilized by the company
and provided to the Cancer Institute.* Internal medical evaluation
of seven (7) and 15-day safety reports involving NYU Cancer
Institute Studies.* Ongoing medical review and monitoring of
adverse events collected and processed for investigational drugs.*
Personal communication with investigators to determine
reportability when the1727 was incomplete.* Provide medical
causality as related to alternative etiology* Reviewed and analyzed
scientific literature and publications to identify Serious Adverse
Events involving the study drugs used in ECOG, NCI, SWOG, and GOG
studies at NYU Cancer Institute
Mar2004 to 25Jan2006 Safety Monitoring Committee Member, NYU*
Responsible for the preparation and presentation of Cumulative
Serious AdverseEvents for clinical trials.
March 2002 - May 2003 Contract Monitors, Inc.Pharmacia - Pfizer:
CRA - Study Monitor* Actively involved in site monitoring of
pathology studies concentrating on inhouse data and reviewed data
as entered in the statistical data base against theclinical
research forms.* Coordinated and interacted with data management
service regarding the monitoring and appropriate documentation of
clinical data and ensured accuracy of data transmission into the
clinical data base.* Reviewed patient's source documents and
narrative reports. Identified errors and inconsistencies and
initiated their resolutions either through the investigat
ive site or the sponsor.* Generate queries to appropriate
personnel at the investigational site and thesponsor and resolved
problematic data identified during the review process. Review
responses to queries for appropriateness and update the data base
accordingly.
PROFESSIONAL TRAININGClinical Research Associate Education and
Training ProgramConducted by Medical Research Management, Inc.
"Fundamentals of Clinical Research" - September 2001
Protocol Development, Case Report from Design, Informed Consent
Writing, GCP 21CFR 312 IND, 21 CFR 50 Protection of Human Subjects,
21 CFR 56 IRB, 45 CFR 46, 21 CFR 54. Financial Disclosure by
Clinical Investigators, International Conference on Harmonization
(E6), GCP Consolidated Guideline and (E2A) Clinical SafetyData
Management.
EDUCATION
Doctor of Medicine Bachelor of Science, Pre-MedicineSouthwestern
School of Medicine, Philippines University of the Philippines
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Urology - General Surgery Residency Urology FellowVeterans'
Memorial Medical Center Southwestern School of Medicine Philippines
Parkland Memorial Hospital
Dallas, Texas
