Safety Scientist

United Biosource Corporation - Blue Bell, PA3.5

Full-time
Brief Description:
The Safety Scientist will be responsible for supporting all operational functions within the Global Case Processing Department (Post-Marketing and Clinical Trials), such as Individual Case Safety Report (ICSR) processing and reporting, Global Literature Review.

Specific job duties:
Assist with the writing of project specific plans and Standard Operating Procedures (SOPs) and with audits/inspections preparation
Process safety reports (post-marketing and/or clinical trials) in a timely manner (adverse event coding, narrative writing, seriousness, causality and expectedness assessment, due diligence and reconciliation) and perform Quality Control
Assess the reportability of safety reports for distribution to Health Authorities, clients and partners and perform submission accordingly
Monitor and review medical literature
Provide and assist with appropriate documentation of non-compliance with regulatory requirements or procedures

Desired Skills and Qualifications:
Registered Nurse (RN), Pharmacist, or other degree in a science or health-related field
Comprehensive knowledge of global and local Pharmacovigilance Regulations and Guidelines for pre and post marketing
Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities
PV processing experience with drugs. Experience with safety surveillance of vaccines, biologics and medical devices is a plus
Proficient with case processing of ICSRs preferably within Argus. Experience with other PV databases (e.g. ARISg) and expedited reporting is a plus
Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel)
Good communication, team oriented attitude, time management and organizational skills are essential
Fluent in English, additional language fluency is a plus
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