Manager, Global Patient Safety, Quality & Compliance

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.
This role will act as an individual contributor, reporting into the head of GPS Quality and Compliance (Q&C).This position is responsible for managing performing, trending and analyzing compliance metrics and associated outputs related to ICSRs and other Global Patient Safety deliverables. This position will also provide support in other tasks for Q&C, as needed.
In this role, a typical day might include the following:

• Manage Global Patient Safety-related non-compliance including the investigation, trending, and requesting supporting documentation and evidence of CAPA implementation based on established documented procedures
• Perform regular trending for compliance-related activities and CAPAs to proactively identify potential trends or significant non-compliance
• Liaise with GCP Quality and other key stakeholders for any significant non-compliance
• Support the conduct of regular and timely review and compilation of compliance outputs based on established documented procedures
• Collaborate with key stakeholders to support audits and inspections as related to compliance
• 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 compliance issues and identify timely solutions
• As needed, assist in review and contribution to Global Patient Safety 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

This role might be for you if:

• We seek Good communication skills, both written and verbal.
• The Ability to multi-task and effectively manage demanding timelines and to work collaboratively across functions and roles.
• Possess a 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
• Knowledge of medical concepts and terminology
• Familiarity with data analytics platforms
• Strong knowledge of safety database
• Minimum 7-9 years pharmacovigilance experience, Healthcare Professional and case processing experience 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 amazing benefits including health and wellness programs, fitness centers and stock for 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 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.

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