Associate, Safety Database User Support

Location
Tarrytown, New York, US
Posted
Aug 31, 2018
Ref
13894BR
Required Education
Associate Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

This position is to support the Pharmacovigilance department in business support of safety systems utilized by the department. This includes daily activities such as making updates in database configuration, user account management, and routine database administrator tasks. It also can include project-specific responsibilities, such as performing validation in support of database-related change controls. This position reports to the Senior Manager, Safety Database User Support, PV, for general supervision.

Duties:

Perform logical deletions in the safety database

• Create/maintain/deactivate new user accounts

• Monitor and troubleshoot electronic submissions in the safety database

• Monitor e-mailbox(es) for safety systems issues and notifications

• Submit requests for new and extended network user accounts

• Assist with documenting, performing, and testing configuration updates in safety database testing environment

• Assist with evaluating user-reported issues of diverse scope

• Assist in execution of Operational Qualification/Performance Qualification test scripts, in support of safety database change controls, and in accordance with Good Documentation Practices

• Assist in generating searches and output in support of requests for safety data

Requirements:

• Working knowledge of Argus safety database

• Familiarity with Argus Console preferred

• Experience with configuration and testing of validated systems preferred

• General knowledge of relevant FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities

• Strong written and verbal communication skills, required for frequent communication with both internal and external contacts
Associates or Bachelors Degree preferred (or equivalent experience). 2 or more years' Pharmacovigilance, database, and/or pharmaceutical experience preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.