Director For Pharmacovigilance & Drug Safety

Pedro S. Dinglasan, M.D.
#2 Arrow Drive
Livingston, New Jersey, 07039
Tel.#: 973-716-0703 Cell#: 973-368-5229
RELEVANT ACCOMPLISHMENTS
* Expanding role in pharmacovigilance from single case medical review to include
signal 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 activi
ties.
* Phase III clinical trial experience to include protocol review and the review
of completed case report forms.
* Past clinical trial internal auditing case documentation and compliance as rel
ated 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 regulatory
guidance of serious criteria
* Multiple therapeutic product responsibilities of both clinical and post-market
ing 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 Jers
ey, USA
Associate Director, Global Pharmacovigilance MSCRM
* Single case medical review including medical evaluation and CIOMS II comments
as related to causal relationship and alternative etiology
* Generate follow-up queries as related to complete medical analysis for a speci
fic event
* Established as an authority for triage and case processing to align safety fol
low-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 s
ystem Organ Class (SOC).
* Identify SUSAR, Death and or life threatening cases and submit them on timely
manner
* Evaluate all serious reports for potential signals that may require a change t
o the existing safety profile of the product.
* Review quarterly line listings with signal specialist to identify any potentia
l safety risks
* Literature review for potential cases
* Preparation of PSUR's sections VII through IX
Pedro S. Dinglasan, M.D.

#2 Arrow Drive
Livingston, New Jersey, 07039
Tel.#: 973-716-0703 Cell#: 973-368-5229
22Jun2007 to 10Sept2007 Ranbaxy, Inc.

Medical Review Officer Drug Safety & Pharmacovigilance
* Assess and review all adverse event cases, provide feedback for follow-up, and
potential signals as related to current safety profile of the product
* Provide other departments with medical opinions regarding products & procedure
s
* Educate and instruct personnel in medically related issues including triage an
d regulatory guidance on serious classification.
* Complete SAE investigations of possible alternative causality for closure & re
porting following data entry and QC.
* Participate in the preparation and submission of PSUR and labeling documents
8Jan 2007 to 30Jun2007 ROCHE, USA, Clifton, New Jersey

Oncology Clinical Science Specialist Pharmaceutical Development
* Actively involved in overall study processing and evaluation of serious advers
e events for all Xeloda Clinical Studies;
* Contributed to study development and providing science input to operation coll
eagues regarding Xeloda Colorectal and Breast Cancer trials
* Evaluation of Serious Adverse Events with feedback for inquiries and subsequen
t production of quarterly safety summaries
* Reconciliation review to determine Reportability of any discrepancies
26Jan2006 - 31Dec2006 Schering-Plough, Springfield, New Jersey, USA

Associate Director, Global Pharmacovigilance - MSCRM
* Retrieve and review the daily Report of Non-Serious Cases as reported by the D
SS, GPV Group with submission of the daily findings to the MS-CRM Group Head
* Review the Non-Serious cases attributed to the drugs assigned to the different
physicians
* Submission of the review of Daily Non Serious Cases linked to the different Th
erapeutic Areas
* Process single cases, promptly notify others of unusual cases and collaborate
with DSS, Aggregate Physicians, and all other parties internal and external to t
he Global Pharmacovigilance Unit
* Review of Serious Adverse Events, Alerts, and Revisions to Case Comments to up
date the recent information; Enter update to data into the CARES Database System
* Generate Medical Reports if changes to Seriousness of events are needed; Secur
e Functions are done in CARES Data Base System
* Review the reported Serious Adverse Events, perform the Medical Review & Evalu
ation, write Risk Assessment Comments and produce PSUR Line Listing Comments in
the CARES Data Base
* Coordinate with the Clinical Group with regards the reports of Serious Adverse
Events per protocol in studies sponsored by Schering-Plough and in Investigator
Initiated studies
* Global Safety Drug Safety functions are coordinated through the worldwide CARE
S System
* Review abstracts of articles for adverse events, signaling issues and new safe
ty information that may influence the existing safety profile of the product
Apr2003- 25Jan2006 NYU-School of Medicine, Cancer Institute

Senior Research Coordinator, Drug Safety
* Contributed to internal audits involving case documentation and compliance of
ECOG cancer studies at St. Vincent's Midtown Manhattan Hospital, New York, NY, V
A Hospital at East Orange, New Jersey and at the Comprehensive Cancer Care Speci
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 respon
sibilities.
* Supervisory role in project teams concerning SAE safety issues as directed by
NYU- IRB
* Review and edit Serious Adverse Events Report forms utilized by the company an
d provided to the Cancer Institute.
* Internal medical evaluation of seven (7) and 15-day safety reports involving N
YU Cancer Institute Studies.
* Ongoing medical review and monitoring of adverse events collected and processe
d for investigational drugs.
* Personal communication with investigators to determine reportability when the
1727 was incomplete.
* Provide medical causality as related to alternative etiology
* Reviewed and analyzed scientific literature and publications to identify Serio
us Adverse Events involving the study drugs used in ECOG, NCI, SWOG, and GOG stu
dies at NYU Cancer Institute
Mar2004 to 25Jan2006 Safety Monitoring Committee Member, NYU

* Responsible for the preparation and presentation of Cumulative Serious Adverse
Events 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 in
house data and reviewed data as entered in the statistical data base against the
clinical research forms.
* Coordinated and interacted with data management service regarding the monitori
ng and appropriate documentation of clinical data and ensured accuracy of data t
ransmission into the clinical data base.
* Reviewed patient's source documents and narrative reports. Identified errors a
nd inconsistencies and initiated their resolutions either through the investigat
ive site or the sponsor.
* Generate queries to appropriate personnel at the investigational site and the
sponsor and resolved problematic data identified during the review process. Rev
iew responses to queries for appropriateness and update the data base accordingl
y.
PROFESSIONAL TRAINING
Clinical Research Associate Education and Training Program
Conducted by Medical Research Management, Inc.
"Fundamentals of Clinical Research" - September 2001
Protocol Development, Case Report from Design, Informed Consent Writing, GCP 21
CFR 312 IND, 21 CFR 50 Protection of Human Subjects, 21 CFR 56 IRB, 45 CFR 46, 2
1 CFR 54. Financial Disclosure by Clinical Investigators, International Confere
nce on Harmonization (E6), GCP Consolidated Guideline and (E2A) Clinical Safety
Data Management.
EDUCATION
Doctor of Medicine Bachelor of Science, Pre-Medicine
Southwestern School of Medicine, Philippines University of the Philippines
Urology - General Surgery Residency Urology Fellow
Veterans' Memorial Medical Center Southwestern School of Medicine Philippine
s Parkland Memorial Hospital
Dallas, Texas

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Director For Pharmacovigilance & Drug Safety

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Pedro S. Dinglasan, M.D.

Pedro S. Dinglasan, M.D.

22Jun2007 to 10Sept2007 Ranbaxy, Inc.

8Jan 2007 to 30Jun2007 ROCHE, USA, Clifton, New Jersey

26Jan2006 - 31Dec2006 Schering-Plough, Springfield, New Jersey, USA

Apr2003- 25Jan2006 NYU-School of Medicine, Cancer Institute

Mar2004 to 25Jan2006 Safety Monitoring Committee Member, NYU

March 2002 - May 2003 Contract Monitors, Inc.

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