Temp - Global Patient Safety Specialist

Location
Tarrytown, NY, United States
Posted
Feb 19, 2021
Ref
23770BR
Required Education
Bachelors Degree
Position Type
Contract
The specialist will be responsible for supporting the Therapeutic Area Head in the successful conduct of global patient safety activities which includes preparation of periodic safety documents and conduct of safety signal activities. You will serve as an in-house subject matter resource for identified area(s). This includes relevant activities in assigned Therapeutic Area program(s) or Business Objects program. We expect the specialist will work without direction and will receive little instruction on day-to-day work with only general instructions on new assignments.
In this role, a typical day might include the following:

The Specialist will work cross-functionally with groups external to GPS to develop timelines and acquire results for: Safety Monitoring Team (SMT) meetings; regulatory documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP); regulatory agency and other ad hoc queries. We need The Specialist to make decisions on moderately sophisticated to complex issues regarding approach for project components, often in ambiguous situations.

Additional responsibilities for the Specialist -

Participate in safety database queries and assist in review and tabulation of query output for: SMT meetings, signal management activities, preparation of regulatory documents, regulatory agency and other ad hoc queries.

Participate in drafting text for query responses and regulatory documents.

Participate in tracking and documentation of signal management activities.

Actively participate in the development and maintenance of relevant SOPs and supporting documents.

Actively participate in process improvement activities within GPS.

Interacts with personnel external to GPS on matters concerning specific compounds or problems.

With limited assistance, applies extensive in-depth and/or broad knowledge skills to perform a variety of difficult assignments of moderate complexity.
This role might be for you if:

You have Degree or Masters in a scientific discipline.

You have relevant clinical experience in the pharmaceutical industry, typically with at least 1-2 years of global patient safety.

You have a solid understanding of MedDRA coding system.

You are familiar with GPS safety system databases.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

BA/MS/PharmD or PhD

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.