Pharmaceutical professional with extensive Pharmacovigilance (PV) experience, a broad knowledge of medical terminology, drugs, therapeutics, and regulatory requirements with a strong background in the critical analysis of biomedical literature to support clients’ information needs
Overview
23
23
years of professional experience
Work History
Lead PV Specialist/PV Specialist
Clarivate/ProQuest/Pi2 Solutions, LLC
01.2012 - Current
Conduct product literature monitoring and ensure the timely completion of indexing and abstracting to fulfill regulatory requirements by overseeing a team of PV specialists and developing strategies to prioritize workflow
Foster and maintain strong client relationships, monitor status of projects, provide monthly metrics for timeliness and output, and verify consistent quality
Serve as lead to a team of PV specialists by allocating work, acting as a subject matter expert, communicating updates/changes, and fostering collaboration
Critically analyze the biomedical literature and identify safety-relevant information obtained through Dialog searches, Reactions Weekly, and Global Medical Information Escalation alerts by employing extensive knowledge of client products, regulatory needs, and product labels
Provide indexing and custom abstracting for articles with a focus on individual case safety reports criteria to support regulatory submissions
Process ad hoc requests and respond to inquiries from the clients' PV teams and subsidiaries
Clinical Literature Analyst
Merck And Co. Inc.
11.2000 - 12.2011
Performed critical analysis of the clinical literature to identify relevant articles for inclusion in Clinical Literature Information Center (CLIC) database with a focus on safety-relevant information
Provided in-depth indexing and created custom-author abstracts of articles in the CLIC database to support various groups within Merck including Regulatory, Marketing, and Clinical Research
Managed literature requests from Global Safety and subsidiaries
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
Merck Research Laboratories (MRL) Communications S
Merck And Co., Inc.
07.2003 - 03.2006
Served as a communication liaison between MRL employees and upper management by participating in the creation and management of an internal web-based portal (MRL Information Network [MRLIN]) that contained relevant and timely employee information
Created weekly story centerpieces for MRLIN 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 Portal
Authored communications and messaging for senior management to be cascaded within in the MRL division
Education
Bachelor of Science - Biology
Chestnut Hill College
Philadelphia, PA
05.1996
Skills
Relationship Building
Adaptability
Problem-solving abilities
Task Prioritization
Teamwork and Collaboration
Timeline
Lead PV Specialist/PV Specialist
Clarivate/ProQuest/Pi2 Solutions, LLC
01.2012 - Current
Merck Research Laboratories (MRL) Communications S