Objective: To utilize my ** years of medical information and drug safety experience in the a forward thinking Pharmaceutical/Biotechnology company either in drug safety or clinical trial work.

Experience:

Bayer Consumer Care

Country PV Life Cycle Manager

Short-term Contract Employee

Drug Safety

March 2010 – September 2010 (Contract defined for six months only. No opportunity for extension.)

• Developed safety sections of submission documents, briefing packages, etc.

• Maintained company compliance with respect to laws, regulations and guidance associated with the licensure of Bayer US products with respect to consumer safety

• Evaluated literature with respect to potential product ingredients and prepare safety assessments and recommendations (i.e. proposed warnings)

• Manage safety assessments of degradation products and impurities

• Responded to US medical inquiries, via written or verbal responses

• Represented the Pharmacovigilance Department Perspectives in the development of US/Global projects

• Provided input to Consumer Relations in development of FAQs and promotional materials

• Managed the aggregate reports process for global regulatory reports

• Ensured Pharmacovigilance principles were represented in clinical protocol, marketing procedures and with the consumer

• Applied current US and international law, regulations and guidelines and assured process compliance

• Wrote the PV components of all domestic study protocols as part of overall Clinical interface and ensure these parts are compliant with the GPV standards and the protocol template.

Hole in the Wall Gang

Project Manager – Non-Profit Organization

January 2009- Present

• Managed the refurbishing, hiring and training of staff for a camp for seriously ill children

Astellas Pharmaceutical US.

Manager Drug Safety Periodic Reports (Post-Marketing, Clinical Trial)

May 2008 – November 2008

• Managed the preparation and analysis of post-marketing safety data for aggregate reports, such as, PSUR and NDA Annual Reports.

• Resolved issues related to evaluation of adverse events, including MedDRA coding, narrative writing and submissions.

• Conducted active pharmacovigilance analyses and signal detection

• Communicated with Clinical Studies personnel and Scientific Liaison regarding issues related to medical evaluation of safety reports.

• Performed trend analysis of adverse event frequency, including reporting rates and data analysis.

• Participated in special safety projects such as pregnancy and other registries, safety white papers.

• Demonstrated proficiency with the global safety database to extract, review, and confirm data applicable to periodic reports or safety analysis.

• Established and maintained professional relationships while collaboratively interaction with intra/interdepartmental colleagues.

• Served as a resource for other teams to review their documents and presentations as appropriate.

Bristol Myers Squibb

Drug Safety Scientist Consultant (Post-Marketing, Clinical Trial)

October 2006 – December 2007

• Compiled and prepared all aspects of aggregate reports (i.e. PSUR, PADER, SUSAR, ASRs and Ad Hoc reports).

• Collaborated with a multi-discipline team (Global Clinical Development, Global Regulatory Sciences, and Pharmacovigilance Plans) at all stages of a product life cycle, including providing medical assessments for these aggregate reports.

• Formulated appropriate and timely responses to queries from internal and external customers, via both written and verbal responses.

• Utilized medical writing skills and Pharmacovigilance analysis skills to produce accurate, concise, medically sound aggregate reports and Risk Management Pharmacovigilance plans suitable for submission to health authorities as necessary

• Revised and wrote SOPS and working practice documents necessary for the training and assessment of new safety scientists, Medical Safety Physicians, Regulatory and Clinical Trials department.

• Developed strong teams to ensure PV processes were adhered across local and Global Pharmacovigilance and Epidemiology Department

• Utilized prioritization skills, the ability to multi-task, and flexibility to meet changing business priorities.

• Maintained a strong skill set and working knowledge of the GPV&E Safety Database (CARES), CARA/PRISM, and I-Review

• Applied sound analytical thinking and database query skills to gather, summarize and evaluate critical information in a timely manner. (for aggregate reports, protocols, investigator brochures, product labels)

• Document and follow-up on product complaints and assist QA in responding to complaints.

Premier Research Group (formerly known as SCIREX Corporation)

Drug Safety Manager-Medical Management and Drug Safety Department (Post-Marketing, Clinical Trial, OTC)

June 2006- September 2006

• Developed SOP's and Working Practice Documents for the processing of Clinical Drug Safety Reports

• Interacted with client corporate representatives and external clients to discuss individual cases management, clinical trial management and case follow- up through resolution.

• Represented Drug Safety management and interests at interdepartmental and inter-company meetings.

• Applied sound clinical judgment to case assessment and IND Safety Report preparation

• Improved the current electronic safety database and filing system,

• Ensured the accuracy and completeness of Adverse Event reports and support information provided to Pharmacovigilance. Data entry and narrative completion in ARISg database.

• Prepared Drug Safety procedures for clinical protocols for phase II through post-marketing studies, including data entry, writing narratives, completing MedWatch or CIOMS forms, aggregate safety reports, and safety profiles used in Investigational Brochures and Protocol Writing.

• Trained Drug Safety and Clinical Affairs Staff , and developed lower level Drug Safety staff, including performance evaluations, safety training enhancement and assist in training as required by other departments

• Processed all aspects of individual case safety report, including data entry, MedDRA coding, narrative writing, triage and submission

Managed Clinical Solutions

Merck Consultant (short-term contract)

August 2005 through May 2006

• VIOXX litigation specialist. Performed in a high volume position requiring exceptional clinical and drug safety skills, narrative writing skills and written communication skills.

• Performed Individual case processing for Worldwide Product Safety and Epidemiology for large post-marketing legal project including the process of legal medical records and extensive medical records.

• Used my strong organization skills to provide quick assessment and triaging of cases and in determination what information is required to be disseminated

• Trained and supervised other Drug Safety Specialists and Coordinators.

• Processed all aspects of individual case safety report, including data entry, MedDRA coding, narrative writing, triage and submission

Human Genome Sciences

Drug Safety Specialist (Clinical Trial)

Jan. 2005 to June 2005 (Short-term contract)

• Performed Individual Case Processing and Quality Assurance Processing for Individual Case Safety Reports according to ICH and FDA Guidelines.

• Applied sound clinical judgment to case assessment and IND Safety Report preparation

• Developed SOP's and Working Practice Documents for the processing of Clinical Drug Safety Reports

• Supervised and wrote aggregate reports, including Ad Hoc requests, investigator brochures and clinical trial protocols.

• Prepared and assisted in the validation, and installation of the ARISg Adverse Experience Database and Fax programs for drug safety department.

• Preparation of Drug Safety procedures for clinical protocols for phase II through post-marketing studies, including data entry, writing narratives, completing MedWatch or CIOMS forms, completing PSUR and Yearly FDA Annual Reports as well as contributing to the safety profiles used on Investigational Brochures and Protocol Writing and Appling sound clinical judgment to case assessment and IND Safety Report preparation

• Developed metrics for data analysis and quality analysis. Serve as resource to and supervise Drug Safety Specialists and Coordinators, Represent Drug Safety management and interests at interdepartmental and inter-company meetings

• Trained Drug Safety and Clinical Affairs Staff and other departmental staff

MedImmune, Inc.

Senior Drug Safety Monitor (Post-marketing, Clinical Trial)

Supervisor, Investigational Drug Safety Case Processing

June 2004- Dec 2004 (Short-Term Contract)

• Performed Individual Case Processing and Quality Assurance Processing for Individual Case Safety Reports for post-marketing, and clinical trials according to ICH and FDA Guidelines.

• Trained Drug Safety and Clinical Affairs Staff. Establish a good working relationship with associated groups, especially clinical trials, project management, medical writing, regulatory affairs, legal, and development/ marketing partners

• Develop SOP's and Working Practice Documents for the processing of Clinical Drug Safety Reports

• Worked on the workflow design for the newly introduced ARISg safety database;

• Assisted in the maintenance of adverse event dictionary. Wrote case medical narratives and medical assessments in the ARISg system.

• Ensured the identification of potential literature resources pertinent to Drug Safety compliance reporting.

• Represented Drug Safety management and interests at interdepartmental and inter-company meetings

• Developed Metrics for data analysis and quality analysis. Maintain filing system integrity for report hardcopy

Guilford Pharmaceuticals Inc.

Manager, Drug Information and Safety (Post-marketing, Clinical Trial)

September 2003 - July 2004

• Chose, implemented, managed and validated the ARISg drug safety database. Assist in the maintenance of adverse event dictionary.

• Ensured the identification of potential literature resources pertinent to Drug Safety compliance reporting.

• Wrote safety section in the formulation, assembly, and submission of regulatory documents as directed.

• Wrote medical narratives and assessments for cases and for Adverse Experience Reports regarding Pre-FDA and Post-FDA approved products through the ARISg system. Provided for the follow-up adverse event reports according to SOP.

• Prepared aggregated reports and other ad hoc safety reports for international health authorities.

• Provided Drug Safety procedures for clinical protocols for phase II through post-marketing studies,

• Served as the source for pharmacovigilance information source for both internal and external clients.

• Implemented and trained outside vendors for handling day-to-day calls from healthcare professionals, consumers, and patients.

• Designed the database for the outside vendor. Designed and implemented call center quality assurance program for monitoring vendor performance.

• Developed a program for outsourcing medical information to call center, training personnel for that call center, and implemented standard letters for distribution through the call center, and managed metrics for in-house deliverables required for the call center to meet.

• Conducted internal quality assurance checks on cases entered in the safety database and spreadsheets.

• Provided accurate, timely, and appropriate responses (oral and written) to requests for product related medical information from internal and external customers. Serve as resource to and supervise Drug Safety Specialists and Coordinators.

• Manage in-house databases to facilitate communication including the creation of template for the most commonly asked medical information questions.

• Ensure a comprehensive and up-to-date library/database of relevant literature associated with the products manufactured or distributed by the company and the health conditions treated with these products.

• Assist in the maintenance of report integrity in the electronic database to manage the dissemination of technical information requested of the Medical Information Service from healthcare professionals, patients, caregivers, and the public.

• Monitored compliance with assigned projects with both in-house and external clients. Ensured prompt, accurate, quality assured responses to requests for medical information from healthcare professionals, patients, and caregivers.

• Development of Slides Kits, Formulary Kits, and Specialized treatment kits for use by the Medical Affairs Department and Marketing Department.

Wolters Kluwer Health- Adis International

U.S. Publishing Project Manager- Clinical Science Liaison- Reprints Department Manager

April 2002 to April 2003

• Worked with global offices in the development, publication and reprints sales of medical manuscripts for 24 Adis journals and 7 newsletters, at any given time managing over 350 different manuscripts each in different stages of development

• Managed publications projects between the editorial teams, the Adis sales teams, the internal and external pharmaceutical clients and key opinion leaders through all aspects of the publication process managing content, timelines, deadlines, budgeting, and vendor reprinting of articles.

• Researched developments in the pharmaceutical marketplace to identity, propose, develop and track new project concepts specifically designed for inclusion in Adis journals

• Clinical Science Liaison discussing scientific content with pharmaceutical clients, key opinion leaders, and Adis Business Development Managers scientific and clinical aspects of all manuscripts as required.

• Technical editing of all manuscripts and review of all manuscripts for FDA US Labeling Regulatory requirements.

• Built strong client relationships by providing high quality customer service, exceptional medical literature products, and products targeted directly at the client’s needs. Develop strong working relationships with Key Opinion Leaders and medical experts for use in manuscript development, article commissioning, and manuscript review processes.

• Hired, managed, trained, coached and motivated the staff of the Reprints Department and other Adis employees including performance management, development of SOPs and quality assurance programs. Assist in development of training materials for Adis Business Development Products.

• Managed vendor deliverables, budgeting on all manuscripts projects, departmental reprint budget

Telerx - a Subsidiary of Merck & Co.

Horsham, Pa.

June 1998 to May 2001

Merck National Service Center Drug Information Specialist-Project Supervisor

Call Center Environment (OTC, Post-Marketed Products)

(Same job description as Guilford Pharmaceuticals)

Roche Diagnostics Contract with Telerx Project Manager (OTC Device Reporting)

• Assist in hiring, training, coaching and motivating of team members for a medical services client. Serve as resource to and supervise Drug Safety Specialists and Coordinators

• Answer in-bound calls pertaining to diabetes self-monitoring devices.

• Resolution of escalated consumer calls and other client service issues. Contribute to training of Drug Safety and Clinical Affairs Staff

• Implement and maintain programs for appropriate monitoring of staff, design of data integrity programs.

• Completion of managerial duties including payroll, scheduling personnel, and communication with the client through reports and conferences.

• Initiate and complete all aspects of Medical Device Safety Reports. Assess individual adverse event report for seriousness, labeling status and relatedness

• Conduct internal quality assurance checks on cases entered in the safety database and spreadsheets.

• Monitor Drug Safety staff compliance with assigned projects. Follow-up adverse event reports according to SOP

Self-Employed Clinical Consultant and Medical Science Liaison

Various Locations

1987 to 1996

• Independent consultant for retail, hospital and long-term care facilities as well as commercial pharmacy software companies.

Education

University of Pittsburgh

B.S. College of Pharmacy 1986

Magna Cum Laude with emphasis in Pharmacology and Pharmacokinetics

University of Pittsburgh

B.S. School of Music 1986

Summa cum Laude- Music Performance and Composition

Community Service

Pharmacy Education Counselor – Hole in the Wall Camps 2005- Present

Brayton Foundation, 1988 to Present, Board Member 1996 to 2004, Present

National Emergency Response Team

Hole in the Wall Gang

YouthAids Volunteer

Awards

Community Service Award 2009, Barretstown Ireland for work with Hole in the Wall Gang

Achievement Award, February 2001 Merck and Company

Performance Award for Merck Cancidas Drug Launch

Quality Achievement Award Telerx 1998, 1999

Computer Training

ARISg, Clintrace, Argus, Oracle AERS, MedDRA Certified

Proficient in all Microsoft Office Products including Excel, Word, PowerPoint, Access and Project,

Management Training

Performance Management and Change Champions Program: Adis International- In depth management course designed to foster methods of strategic thinking and problem solving and to strengthen team-building skills through performance management, motivational speaking and interdisciplinary team building

Adis International – Effective medical writing.

Performance Management and Team Building Program Electronic Data Services (EDS)

Courses on Global Leadership, and Effective Leadership Skills.

Working effectively with Personality styles

Working effectively with global colleagues.

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