Drug Safety Associate
Job Description
Title: Senior Safety Associate (Global Case Management)
Location: Cambridge, MA
Duration: 8 - 12 Months+
Job Summary
The Safety and Benefit Risk, Global Case Management department performs pharmacovigilance activities, ensuring timely adverse event reporting in compliance with applicable laws and regulations/company policies throughout the lifecycle of products. The candidate will function as an integral part of the Global Case Management team, working under the direction of a manager, to meet department objectives or assist on special projects within established deadlines.
Requirement:
• Completes Medical Data Entry in the Global Safety Database (GSD), including the generation of medical narratives, and ensures accurate coding in the GSD.
• Performs Peer Quality Control to ensure completeness, accuracy, and overall high quality of adverse event data entered into the GSD.
• Participates, in data clean-up activities in support of the global safety database migration.
• Executes the User Acceptance Testing (UAT) database scripts to ensure accuracy and functionality of the new database.
• Assists with ad hoc activities identified following the implementation of the new database.
• Assists with testing and executing change request post database migration.
• Assists with ad hoc projects.
Qualifications:
• Has at least 3+ years of experience in pharmacovigilance.
• Current working knowledge of AERS, and/or ARISg Global Safety Databases.
• Has post-marketing, observational study, and interventional study case processing experience.
• 1+ years of experience with hands on patient care in a clinical setting is preferred
Education:
• PharmD, nurse or other relevant healthcare or life science discipline.
Feel free to forward my email to your friends/colleagues who might be available
Thanks!!!
Warm Regards,
Amrit Singh
Clinical Recruiter
Integrated Resources, Inc.
IT REHAB CLINICAL NURSING
Tel: (732) 429 1634 (Direct)
Ext: (732) 549 2030 x (212)
Fax: (732) 549 5549
http://www.irionline.com
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012, 2013 & 2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
https://www.linkedin.com/company/46970?trk=prof-exp-company-name