Medical Safety

Pedro S. Dinglasan, M.D.

#* ***** *****

Livingston, New Jersey, 07039

Tel.#: 973-***-**** Cell#: 973-***-**** E-Mail: **********@*****.***

RELEVANT ACCOMPLISHMENTS

•Pharmacovigilance and drug safety roles from medical review of serious single cases; signal detection and their medical evaluation and aggregate responsibilities with PSUR, ASR and QSR production.

•Signal detection activities with data mining, evaluation and report production

•Multiple therapeutic product responsibilities of both clinical and post-marketing events involving oncology, hepatology, respiratory, cardiovascular, antifungal and HIV drugs

•Competency in MedDRA coding and the triage of serious reports

•Contributed to the development of ongoing safety monitoring plans and of SOP associated with pharmacovigilance activities.

•Broad clinical trial experience which included protocol review, IRB coordination and the review of completed case report forms.

•Past clinical trial internal auditing case documentation and compliance as related to oncology studies (ECOG)

•Cross-trained in safety databases including Oracle-AERS, Roche Advent System, and Argus

EMPLOYMENT HISTORY

Medical Reviewer

Medical Director, Pharmacovigilance & Drug Safety

Eisai Company, Ltd

March, 2016 – August,2016

Woodcliff Lake, New Jersey

Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events

Assesses the relationship between drugs and adverse events

Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review

Participates in the training of the Safety Specialist and Coordinators

Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely medical review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities

Medical Director, Pharmacovigilance & Drug Safety

Tarceva, Enzalutamide and Lipitor Group

June 2014 – August 2015

Inventiv Health Clinical

Somerset, New Jersey - Home Based, Livingston,NJ

•Director Physician for Medical Review of Oncology and Lipitor Products

•Performs Medical Review and Triage and Assessments of serious and non serious cases in Invent Health ARGUS Safety Database with accurate MEDRA coding of events in a timely manner providing scientifically sound medical comments

•Knowledge of CFR and ICH Guidelines for drug safety surveillance with review for scientific correctness information processed on adverse events Ensure AE reports are processed and evaluated in compliance with regulations, guidelines, SOPs and internal processes.

•Cooperate with safety professionals in Europe, Americas and India to ensure that product safety profiles are acted upon appropriately and in a timely manner

•Provide medical support and advice to non-physician personnel

Medical Director, Pharmacovigilance & Drug Safety

OTC, Nutritional, Enbrel & Active Moiety Group

Alacer & Ferrosan Migration Project

June 2012 – May 2013

Pfizer Pharmaceutical, Inc.

Bridgewater, New Jersey

•Lead Physician for Ferrosan and Alacer Project for integration with Pfizer Safety Data Base

•Performs Medical Review and evaluation of serious and non serious cases in Pfizer ARGUS Safety Database with correct choice of events and their coding

•Performs confirmation of choice of events and their MEDRA Coding for assigned cases prior to Medical Review and final submission

•Performs the correct process for the migration of Alacer and Ferrosan cases into the Pfizer Argus Safety Database

•Performs Medical Review of Enbrel Cases together with the Active Moiety Cases

Medical Director, Global Pharmacovigilance

Cubist Pharmaceutical, Inc.

Lexington, Massachusetts

October 2010 – March 2011

•Performs single case medical review and evaluation in AERS safety database with proper coordination with Senior Specialists and Medical Monitors regarding events and coding issues

•Plays an active role in signal detection management plans for future use in the proper identification and reporting of possible signals with possible submission to safety committee

•Performs MEDRA Coding of events for reconciliation of Cubicin cases

•Involved in the preparation of the new Medically Significant Listing

•Actively involved in the harmonization of event terms in the updated Company Core Data Sheet

Associate Director, Global Pharmacovigilance – Medical Services Clinical Risk Management

Merck, Springfield, New Jersey

September 2007 to June 2010

•Single case medical review including medical evaluation and CIOMS II comments as related to causal relationship and alternative etiology

•Preparation of PSUR’s sections VII through IX, Annual Safety Reports and Quarterly Reports

•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 utilizing historical safety information provided in PT summary reports delineated by System Organ Class (SOC).

•Identify SUSAR, Death and Life Threatening cases and submit them in a timely manner

•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

•Medical Literature review of printed articles to identify potential case

Medical Review Officer – Drug Safety & Pharmacovigilance

Ranbaxy Pharmaceuticals, Inc., Princeton, New Jersey

June 2007 – September 2007

•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 & procedures

•Educate and instruct personnel in medically related issues including triage and regulatory guidance on serious classification.

•Complete SAE investigations of possible alternative causality for closure & reporting following data entry and QC.

•Participate in the preparation and submission of PSUR and labeling documents

Oncology Clinical Science Specialist – Pharmaceutical Development

ROCHE, Clifton, New Jersey

January 2007 – June 2007

•Actively involved in overall study processing and evaluation of serious adverse events for all Xeloda Clinical Studies

•Contributed to study development and provided scientific input to operation colleagues working on Colorectal and Breast Cancer trials using Xeloda

•Evaluation of Serious Adverse Events with feedback for inquiries and subsequent production of quarterly safety summaries

•Reconciliation review to determine Reportability of any discrepancies

Associate Director, Global Pharmacovigilance – Medical Services Clinical Risk Management

Schering-Plough, Springfield, New Jersey

January 2006 – December 2006

•Retrieve and review the daily report of Non-Serious Cases reported by the DSS-GPV Group with submission of the daily findings to the MS-CRM Group Head

•Medical Review of cases with Serious Adverse Events, write the 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

•Review abstracts of articles for adverse events, signaling issues and new safety information that may influence the existing safety profile of the product

Senior Research Coordinator and Drug Safety Specialist for Clinical Trials

NYU – School of Medicine, Cancer Institute

April 2003 – January 2006

•Contributed to internal audits involving case documentation and compliance of ECOG cancer studies at St. Vincent’s Midtown Manhattan Hospital, New York, NY; VA Hospital at East Orange, New Jersey and at the Comprehensive Cancer Care Specialist 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 auditing and submission to review board.

•Lead role for project teams involving SAE safety issues as directed by NYU- IRB

•Review the serious adverse events forms used by pharmaceutical companies and provided to the Cancer Institute.

•Internal medical evaluation of seven (7) and fifteen (15) day safety reports involving NYU Cancer Institute Clinical Trial Studies.

•Direct communication with investigators to determine accurate medical causality

•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 the NYU Cancer Institute

Safety Monitoring Committee Member

NYU – School of Medicine, Cancer Institute

March 2004 – January 2006

•Responsible for the preparation and presentation of Cumulative Serious Adverse Events for clinical trials.

•Identify possible signaling events from reported events from Clinical Trials

CRA – Study Monitor/Medical Monitor

Pharmacia – Pfizer Contract Monitors, Inc.

March 2002 – May 2003

•Actively involved in site monitoring of pathology study reports entered in the statistical database against the clinical 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 investigative site or the sponsor.

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,

21 CFR 54. Financial Disclosure by Clinical Investigators, International Conference on Harmonization (E6), GCP Consolidated Guideline and (E2A) Clinical Safety Data

Management

EDUCATION

Doctor of Medicine

Southwestern School of Medicine, Philippines

BS, Pre-Medicine

University of the Philippines

Urology - General Surgery Residency

Veterans' Memorial Medical Center

Urology Fellow – Parkland Memorial Hospital, Dallas Texas

Contact this candidate