Drug Safety Associate

Drug Safety Associate

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

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

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.