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Pharmacovigilance Management

Green Lane, PA, 18054
August 07, 2012

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•Pharmaceutical professional with large global and small pharmaceutical experience, concentrated in Pharmacovigilance/Drug Safety with active support of Research & Development, Clinical Operations, Quality Assurance, Regulatory Affairs, and Medical Affairs

•Strong medical writing experience, including authoring narrative summaries and regulatory safety reports for serious adverse events in oncology, cardiovascular, central nervous system, gastrointestinal, hormone replacement, endocrine, respiratory and inflammatory disease, and pain management therapeutic areas

•Supported successful NDA and sNDA submissions for cardiovascular, oncology, and gastrointestinal products, and represented Pharmacovigilance/Drug Safety for FDA Advisory Committee Meeting sponsor presentation

•Superior communication, writing, and interpersonal skills, and firm understanding of current FDA, ICH, and GCP regulations



November 05, 2001 – May 31, 2012

(Acquired by Cubist Pharmaceuticals, Inc. Dec 2011)

Director, Pharmacovigilance/Drug Safety

•Authored all Standard Operating Procedures and Working Practice Documents for Pharmacovigilance/Drug Safety

•Authored and maintained Pharmacovigilance Plan agreements between the sponsor and Contract Research Organizations

•Negotiated, developed, and approved Safety Data Exchange Agreements between the sponsor and corporate affiliates to ensure local and international regulatory reporting compliance

•Developed, documented, and managed investigational clinical trial and post-marketing adverse event reporting processes and aggregate analysis strategies to ensure compliance with FDA regulations, ICH guidelines, and Risk Evaluation and Mitigation Strategy (REMS) requirements

•Maintained a regulatory authority reporting compliance level of 99.5% over ten years

•Provided content to support pharmacovigilance monitoring, reporting and analysis process guidance, and created templated sections for Clinical Trial Protocols, electronic and paper Clinical Trial Case Report Forms (CRFs), CRF Completion Guidelines, Clinical Study Reports, Investigator Brochures, and Informed Consent documents

•Established and authored Developmental Core Safety Information for investigational products

•Compiled, prepared and presented documentation and summaries required for interdisciplinary Safety Review Committee meetings for all programs, in collaboration with the Chief Medical Officer or physician Head of Pharmacovigilance/Drug Safety

•Administrated the Pharmacovigilance/Drug Safety database, including user maintenance, training, and managing modifications, upgrades and validation

•Developed, established, and managed processes involving a vendor call center for adverse event and product complaint reporting, weekly reconciliation, and literature search activities

•Developed and delivered Pharmacovigilance/Drug Safety training presentations to physician investigators and clinical trial study coordinators

•Interacted with Clinical Trial Investigators, Study Coordinators, and Clinical Research Associates for retrieval of medical information and clinical trial documentation in support of Phase I to Phase IV clinical trials

•Developed and implemented Pharmacovigilance training materials specific to field-based staff

•Advised senior management regarding departmental budget and resource planning


GLAXOSMITHKLINE (formerly SmithKline Beecham), Collegeville, PA

March 1995 – November 2001

Senior Clinical Safety Scientist

•Managed serious adverse event processes, expedite reporting, workflow management and signal detection for clinical trials in oncology, cardiovascular, central nervous system, hormone replacement, and endocrine (diabetes, Type 2), and respiratory and inflammatory disease therapeutic areas

•Provided Drug Safety training to physician investigators and clinical trial study coordinators

•Represented Drug Safety for development of Integrated Standard Operating Procedures and Working Practices following the 2000 merger of Glaxo Wellcome and SmithKline Beecham

•Reviewed, evaluated, and provided recommendations for development of Clinical Trial Protocols and Case Report Forms

•Served as point person within Drug Safety for clinical trial protocols utilizing electronic Remote Data Management

•Represented Clinical Trial Drug Safety for MAA/sNDA working group meetings

•Reviewed, edited and managed timely delivery of all safety data in support of a successful sNDA submission for a chemotherapy product (small-cell lung cancer indication)

•Reviewed, edited and managed timely delivery of patient narratives in support of a successful NDA submission for a chemotherapy product (ovarian cancer indication)

•Managed the development and performance review for a staff of six

Additional Related Experience:

GRAND VIEW HOSPITAL, Sellersville PA - Medical Technologist

LAWRENCE MEMORIAL HOSPITAL, New London CT - Medical Technologist

CAPE COD HOSPITAL, Hyannis MA - Medical Technologist


Bachelor of Science (Medical Technology)

Rutgers University, Livingston College, New Brunswick, NJ

Medical Technologist, BSMT (ASCP)

American Society of Clinical Pathology

Clinical Laboratory Scientist, NCA (CLS)

National Credentialing Agency for Laboratory Personnel


•Drug Information Association

•American Society of Clinical Pathology


•Microsoft Office

•Microsoft Visio

•MedDRA Web-Based Browser

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