Senior Manager, Safety Database User Support, PV

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 reviewing user requirements for database configuration requests, and assessing and testing configuration updates before releasing to Production. It also includes project-specific responsibilities, such as contributing to and reviewing user requirements for new PV systems, contributing to validation documentation, and performing support of database-related change controls. The position may be called upon to assist with training end users on database-specific updates, and troubleshooting user-reported issues. This position reports to the Senior Manager, Safety Database User Support, PV, for general supervision.

Job Duties:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

• Work with PV end users to develop configuration requirements; document, perform and test configuration updates in the safety database testing environment

• Provide support for configuration and ongoing support of electronic reporting for health authorities and partners

• Troubleshoot user-reported issues of diverse scope

• Liaise closely with the Global Development Systems safety systems team and managed service team, in the support and maintenance of the PV safety systems

• Contribute to and review user requirements for new PV systems projects; contribute and review project-related validation documentation

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

• Generate database searches and output in support of requests for safety data

• As needed, assist in providing end user training on safety system related updates to internal PV staff and external vendors responsible for case processing

• As needed, assist in review and contribution to Safety Database User Support-related SOPs, Work Instructions and Job Aids

Requirements:

• Strong knowledge of safety database (Argus preferred)

• Strong knowledge of front-end database configuration (Argus Console preferred)

• Knowledge of generating advanced searches and developing reporting output

• Experience in working with case intake systems preferred

• Experience with configuration and testing of validated systems

• 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

Minimum 5 years' PV experience, with a minimum of 2 years' safety database-specific experience.

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.