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Manager, Global Patient Safety Quality & Compliance

Employer
Regeneron Pharmaceuticals, Inc.
Location
United States
Start date
Oct 8, 2024
View more categoriesView less categories
Discipline
Administration, Clinical, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Regeneron is seeking a Manager, Global Patient Safety Quality and Compliance role, reporting into the Associate Director of Quality and Compliance (Q&C). This position is responsible for performing quality review tasks related to ICSRs and other GPS deliverables including conducting quality control review of individual case safety reports. This position will also provide support in other tasks for Q&C, as needed.

In this role, a typical day might include:

  • Conducting regular quality control review of ICSRs based on established documented procedures

  • Conducting quality control reviews of Global Patient Safety deliverables including Safety Agreements and Safety Management Plans

  • Generating and reviewing metrics related to quality control of ICSRs

  • Performs regular trending of quality results to identify potential trends

This role might be for you if can:

  • Effectively manage workload to ensure overall compliance with GPS standards and timelines

  • Work effectively with other GPS sub-functions and relevant personnel to support GPS quality issues and identify timely solutions

  • Support audits and inspections related to GPS as needed

  • As needed, assist in review and contribution to GPS Quality and Compliance-related documented procedures

  • Support deliverables as needed for GPS Quality & Compliance

  • Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.

To be considered for this opportunity, you must have the following:

  • Minimum Bachelor's Degree with 5+ years pharmacovigilance experience including case processing experience, health-care professional preferred

  • Effective and clear communication skills, both written and verbal.

  • Ability to effectively manage demanding timelines

  • Ability to work collaboratively across functions and roles High level of accountability; drive results

  • Understanding of global safety reporting regulations and guidelines including FDA, ICH, and GVP Strong computer skills and experience working with the Microsoft programs (Word, Excel, PowerPoint, Outlook, Teams)

  • Knowledge of medical concepts and terminology Strong knowledge of safety database (Argus preferred)

#GDPSJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$110,900.00 - $181,100.00

Company

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.  

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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