The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for our Ophthalmology compound(s) and is the GPS representative on the cross functional Strategic Program Team for the compound(s). The GPS Lead creates the safety strategy and ensures optimal support is provided from within the GPS organization and works collaboratively with cross-functional stakeholders to implement the safety strategy. This position requires the ability to partner with and positively influence colleagues in a matrix environment within and external to GPS, including senior management. The GPS Director joins Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and post-marketing activities in all relevant global territories.
In this role, a typical day might include the following:
This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products including safety surveillance, signal management, communication of the safety profile, benefit risk assessment, safety responses to regulatory agency or ethics queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, risk assessments etc.). Specific activities include, but are not limited to, the following:
- Leading cross-functional Safety Monitoring Team (SMT) activities
- Representing Global Patient Safety for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs)
- Proactively identifying, creating and updating safety strategies and risk assessments
- Participating in and adding value to non-compound specific Global Patient Safety activities
- Providing Subject Matter Expertise for medical review and interpretation of complex ICSRs and other data sources (literature, post-marketing data, real-world evidence, product technical complaints etc.) for assigned compounds
- Actively participate in the development and maintenance of relevant SOPs, working practices and best practice guidelines
- Actively participate in continuous improvement activities within both the therapy area and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists
This role might be for you if:
- You have a deep knowledge and ability to interpret and apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
- Naturally function as a subject matter expert, both internally and externally, for assigned compounds.
- Have relevant clinical and/or industry experience in the therapeutic area of ophthalmology and device vigilance.
- A proven ability to lead and develop a diverse team of safety professionals in an inclusive and goal-oriented environment.
- A proven ability to positively influence at all organizational levels, communicate appropriately, and clearly explain the implications of safety data and make plan risk management and minimization activities.
- A proven ability to interrogate the safety database for purposes of medical case review and simple queries (understanding of data entry and retrieval in the database, use of MedDRA dictionary and SMQs/CMQs and manipulation of data outputs for the purposes of data analysis)
- A minimum of 10+ years of total relevant experience in pharmacovigilance and/or ophthalmology and a PharmD / PhD / MD degree and experience in safety science including significant experience with authoring aggregate reports
- Relevant experience (minimum of 2+ years) of device vigilance.
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.