Manager, Manager, Quality Review, Q&C, Pharmacovigilance

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
16977BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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 is an individual contributor role, reporting into the head of Quality and Compliance (Q&C).
This position is responsible for performing quality review tasks related to ICSRs and other PV deliverables. This position will also provide support in other tasks for Q&C, as needed

Responsibilities:
  • Conducts regular quality control review of ICSRs based on established SOPs, Work Instructions and Job Aids
  • Conducts quality control reviews of Pharmacovigilance deliverables including Safety Agreements, Periodic Adverse Experience Reports, and Safety Management Plans
  • Perform regular trending of quality results to identify potential trends
  • Effectively manages workload to ensure overall compliance with PV standards and timelines
  • Work effectively with other PV sub-functions and relevant personnel to discuss quality issues and identify timely solutions
  • As needed, assist in review and contribution to PV Quality and Compliance-related SOPs, Work Instructions and Job Aids
  • Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly

Requirements:
  • Good communication skills, both written and verbal.
  • Ability to multi-task and 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)
  • Knowledge of medical concepts and terminology
  • Strong knowledge of safety database (Argus preferred)

Education

• Bachelor's Degree in life sciences required

• Pharmacy, nursing or equivalent required, advanced degree preferred.

Experience

• Healthcare Professional with 4-6 years pharmacovigilance experience, case processing 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.