Pharmacovigilance Intelligence Analyst
Deerfield, IL
Req ID 49779BR
Business Title
Pharmacovigilance Intelligence Analyst
Business
Global Quality
Sub-Business
Global Pharmacovigilance
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
This position will be part of the Pharmacovigilance Intelligence/Safety Writing Group within the Pharmacovigilance organization. The successful candidate will be participating in the analysis of pharmaceutical regulations applicable to pharmacovigilance. This will include analysis of regulatory documents, preparation of summary and position papers and training on new regulations. The successful candidate will work directly with the SOP management team to align SOPs and other documents across Pharmacovigilance.
Responsibilities include, but are not limited to:
•Analysis of documents from regulatory authorities globally that affect Pharmacovigilance
•Develop and present training materials on new regulations
•Support SMEs and management in developing overall strategies and processes for implementation of new regulatory documents into SOPs and processes
•Development of summary and position papers
•Preparation of responses to regulatory documents
•Assist in the management of project timelines in a global team environment
•Represent Pharmacovigilance Intelligence on cross functional teams as needed
•Participate in teams and committees as assigned
Job Requirements
•Demonstrated expertise in interpretation and analysis of regulatory documents related to PV
•Knowledge of US and Ex-US Pharmacovigilance Regulations
•Excellent analytical and problem solving skills
•Excellent oral and written communication and interpersonal skills
•Ability to work with interdisciplinary, highly matrixed teams
•Proficiency working in Windows-based work processing and medical/scientific/regulatory databases/resources
•Strategic Planning and Problem Solving - Assist in the analysis of regulatory documents and in the identification of gaps and risks to current processes
•Scientific and Technical Analysis - Execute routine communications with internal and external parties at the Regional and Local levels
•Risk Assessment and Contingency Planning - Implement plans for assigned projects including identification and communication of potential risks/stop gaps in alignment of processes in Pharmacovigilance functions Education and/or Experience
•Bachelors Degree in healthcare or life science from an accredited college or university required
•Advanced Degree in healthcare or life science is desired
•Working knowledge of US and Ex-US pharmaceutical regulations
•5+ years of experience in analysis of regulations related to PV in a pharmaceutical company required
•Demonstrated proficiency with MS PowerPoint is strongly desired
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
