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
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.