Drug Safety Associate

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