Director, Global Patient Safety

Location
Tarrytown, NY, United States
Posted
Sep 06, 2020
Ref
16535BR
Required Education
Doctorate/PHD/MD
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.

Reporting to the Global Patient Safety (GPS) TA Lead, the Director, GPS provides PV and RM expertise, leadership, and mentorship of team members within the TA matrix. You may also have direct management of relevant GPS personnel. Responsible for contributing to the management of, and have shared accountability for the safety profile with the TA. This includes results that support products within the assigned portfolio. This position requires ability to work with and influence colleagues in a matrix environment and with senior management. This is a key member of the GPS TA team. The Director has a major impact on drug development and commercialization decisions, strategies and operations, in all relevant territories globally.
In this role, a typical day might include the following:
With oversight from GPS TA Lead (Ex Dir of Sr Dir), responsible for all GPS activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc); review and contribute to clinical documents (Investigator Brochures, protocols, clinical study reports, etc) focusing input on safety sections. Lead cross-function Safety Monitoring Team activities.
Represent GPS for assigned compounds on cross-functional teams, including but not limited to Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron.
Proactively identify and develop plans/ strategies for non-compound specific Global Patient Safety activities. Resource for medical review of assigned compounds. Actively participate in the development and maintenance of relevant SOPs and working practices. Actively participates in continuous improvement activities within both the TA and the GPS organization
This role might be for you if:
  • You have the ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
  • Function as an SME internally and externally to GPS for assigned compounds.
  • Have the ability to utilize PVRM safety database for purposes of medical case review and simple queries.
  • Are able to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
  • MD highly preferred.
We are seeking individuals with more than 4+ years total proven experience in GPS or equivalent including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with proven achievements in safety (ex. supporting an ISS; responsible for CSR content).

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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Requirements:

Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. Function as a subject matter expert internal and external to PVRM for assigned compounds. Ability to utilize PVRM safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.

MD required with Clinical experience and 2 - 4+ years of industry experience in drug safety including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).

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.