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Assoc Dir GPS Quality & Compliance

Employer
Regeneron
Location
Dublin, Ireland
Salary
Competitive
Start date
4 Apr 2024
Closing date
4 May 2024

View more

Discipline
Quality, Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Summary: This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety (GPS). Such activities include developing, performing, trending and analyzing quality and compliance metrics and associated outputs related to Safety Sciences Quality & Compliance deliverables. This role will be reporting into the head of GPS Quality and Compliance (Q&C) and requires people management.

Job Duties:

 

  • Develop and execute a compliance and quality oversight governance for GPS Safety Sciences deliverables including, but not limited to, Risk Management Plans, Signal Management, and the Pharmacovigilance System Master File.
  • Establish and refine key performance indicators to ensure overall quality and compliance with associated with GPS Safety Science deliverables.
  • Liaise with GPS subject matter experts, Regulatory Affairs, Medical Affairs and other key functions on key performance indicators and proactively identify potential trends or significant non-compliance.
  • Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events based on established documented procedures associated with benefit-risk deliverables.
  • Provide support, for quality review of additional GPS deliverables, including but not limited to, Safety Agreements and Safety Management Plans.
  • Support GPS-related audits and inspections.
  • As needed, assist in review and contribution to Global Patient Safety Quality and Compliance-related documented procedures.
  • Effectively manage workload to independently ensure overall compliance with standards and timelines.
  • Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions.
  • Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.
  • Responsible for management of assigned Quality & Compliance staff as applicable; this includes but is not limited to management of job performance, career development and training.


Job 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.
  • Strong 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.
  • Familiarity with data analytics platforms.
  • Strong knowledge of safety database.
  • Expertise in benefit-risk management.
  • Bachelor's Degree, minimum 10-years pharmacovigilance-related experience, healthcare professional preferred.


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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

 

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