Accomplished PV Manager with a demonstrated record of optimizing workflow and enhancing team performance. Expertise in complex problem-solving and building robust client relationships, underpinned by broad knowledge of medical terminology, drugs, therapeutics, and regulatory requirements. Proven ability to conduct critical analysis of biomedical literature to effectively meet client information needs. Committed to driving operational excellence and delivering impactful results.
Overview
27
27
years of professional experience
Work History
PV Manager/Lead PV Specialist/PV Specialist
Clarivate Analytics/ProQuest/Pi2 Solutions, LLC
Philadelphia, PA
01.2012 - Current
Lead a team of PV Specialists to ensure the timely completion of literature monitoring and the delivery of Individual Case Safety Report (ICSR) data to support regulatory requirements and standards
Develop new strategies to optimize workflow/processes, improve team performance, and drive business success
Provide ongoing team training to support client needs; maintain up-to-date awareness of new drugs and therapeutic, safety signals, and changes in biomedical technology; and facilitate communication and knowledge sharing within a remote global workforce
Cultivate strong client relationships, monitor the status of projects, provide monthly metrics for timeliness and output, and verify consistent quality through QC and audit support
Collaborate across teams to troubleshoot and problem solve
Critically analyze the biomedical literature and identify safety- relevant information obtained through imports from Medline and Embase
Perform indexing and abstracting of clinical articles to ensure precise and complete retrieval from the client’s database
Conduct regulatory and client-request searches of in-house database and commercial databases such as Embase and Medline
Clinical Literature Analyst
Merck & Co. Inc.
Blue Bell, PA
11.2000 - 12.2011
Performed critical analysis of the clinical literature to identify relevant articles for inclusion a product literature database with a focus on safety-relevant information
Provided in-depth indexing and created custom summaries of articles in the CLIC database to support various groups within the Company including Regulatory, Marketing, and Clinical Research
Collaborated with other groups within Merck including Labeling and the Japanese subsidiary Banyu to provide proofreading and editorial support
Translated clinical articles from Spanish to English
MRL Communications Specialist
Merck & Co., Inc.
West Point, PA
07.2003 - 03.2006
Served as a communication liaison between Merck Research Laboratory (MRL) employees and upper management by participating in the creation and management of an internal web-based divisional portal that contained relevant and timely employee information
Created weekly story centerpieces to highlight new breakthrough research, scientific discoveries, employee contributions/accomplishments, worldwide scientific events, and Merck legacy/history
Collaborated with MRL upper management and Human Resources to address employee questions and concerns submitted anonymously through the website
Authored communications and messaging for senior management to be cascaded within in the MRL division
Editor/Analyst
Institute For Scientific Information
Philadelphia, PA
11.1999 - 11.2000
Screened the scientific literature (journals, magazines and newspapers), selected clinical and non-clinical articles to be included in the client's product literature database, and performed detailed abstracting and indexing of all articles for optimal retrievability
Organ Procurement Coordinator
National Disease Research Interchange
Philadelphia, PA
07.1998 - 06.1999
Served as a liaison between organ transplant centers and researchers across the U.S. to place donated human tissue and organs by establishing relationships with organ banks and medical professionals, taking detailed patient medical history, determining the optimal placement of the organs/tissue based on researchers' criteria, and arranging appropriate transportation for time-sensitive biological material
Education
Bachelor of Science -
Chestnut Hill College
Philadelphia, PA
05-1996
Skills
Complex Problem-solving
Documentation and reporting
Key performance indicators
Contract management
Project management
Staff management
Timeline
PV Manager/Lead PV Specialist/PV Specialist
Clarivate Analytics/ProQuest/Pi2 Solutions, LLC
01.2012 - Current
MRL Communications Specialist
Merck & Co., Inc.
07.2003 - 03.2006
Clinical Literature Analyst
Merck & Co. Inc.
11.2000 - 12.2011
Editor/Analyst
Institute For Scientific Information
11.1999 - 11.2000
Organ Procurement Coordinator
National Disease Research Interchange
07.1998 - 06.1999
Bachelor of Science -
Chestnut Hill College
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