Senior Director, Global Patient Safety
3 months ago
Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head of General Medicines, the Senior Director is a key role that contributes to the success of Regeneron’s novel gene therapy approach. This position serves as the primary contact within the TA for all safety-related issues for the assigned compound(s) focusing mainly on supporting the advancement and commercialization of our gene therapy portfolio.
In this role, a typical day might include:
Representing GPS on key product safety governance teams as Chair of the Safety Management Team (SMT) and a member of the cross-functional Strategic Program Team (SPT). The incumbent leads the development of safety strategy, collaborates to ensure optimal support from within GPS and with cross-functional stakeholders to deliver the safety profile and the safety strategy. This position employs hands-on knowledge and proven expertise monitoring safety of advanced therapies including biological medicines and gene therapy products. This position requires the ability to work with and influence colleagues of all organizational levels, including senior management, in a matrix environment.
This role might be for you if can:
Serve with direct responsibility for overseeing all aspects of GPS safety monitoring activities for assigned compounds (primarily gene therapy) to drive safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, RMPs, etc.) and review / provide PV input for clinical documents (Investigator Brochures, protocols, clinical study reports, and other relevant study documents)
Lead cross-functional meetings including Safety Monitoring Team (SMT) activities
Represent GPS 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)
Serve as delegate for GPS Therapeutic Area Head of General Medicines (GM), as needed
Help to evolve the GPS methods to cover gene therapies and advanced technologies.
Proactively identify and develop safety strategies and planning for non-compound specific GPS activities (e.g., mechanism of action)
Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds
Actively participate in the development and maintenance of relevant SOPs, working practices and guides
Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists
To be considered for this opportunity, you must have the following:
5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu of a PharmD / PhD / MD degree 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)
Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices
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 GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.
Thorough understanding of drug development and context as applicable to safety surveillance activities
A proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment.
An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.
Ability to utilize GPS safety database for purposes of medical case review and simple queries.
#MDJobsRA #MDJobs #GDPSJobs
-
Director, Global Patient Safety Sciences
3 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeThe Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) [asset(s)] assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and...
-
Associate Director, Global Patient Safety Scientist
2 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeThe Associate Director, Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety...
-
Assistant Director of Nursing
1 month ago
Dublin, Ireland Beacon Hospital Full timeJob Title; Assistant Director of Nursing / Patient Flow Department ; Nursing Administration Reporting Relationship ;Director of Clinical Services Date ; 2024 Purpose of the Post: The Assistant Director of Nursing Patient Flow (ADON) will report to the Director of Clinical Services in the day to day clinical operations. This will...
-
Assistant Director of Nursing
1 month ago
Dublin, Ireland Beacon Hospital Full timeJob Title; Assistant Director of Nursing / Patient Flow Department ; Nursing Administration Reporting Relationship ;Director of Clinical Services Date ; 2024 Purpose of the Post: The Assistant Director of Nursing Patient Flow (ADON) will report to the Director of Clinical Services in the day to day clinical operations. This will involve the...
-
Assistant Director of Nursing
1 month ago
Dublin, Ireland recruitNet Full timeRecruitNet International Ltd is specialising in relocating qualified professionals throughout Ireland and overseas, we guide you through professional registration, job placement, visa, and employment permit processing.We are hiring a Assistant Director of Nursing / Patient Flow for a Private Hospital in Dublin , Ireland. We will provide exceptional...
-
Global Director of Regulatory Affairs
3 months ago
Dublin, Ireland Next Generation Full timeExciting Opportunity: Global Director of Regulatory Affairs Company Overview: Our client, an expanding global biopharmaceutical company, is at the forefront of innovation in oncology therapeutics. With a commitment to improving patient outcomes, they are expanding their therapeutic portfolio and seeking a talented Global Director of Regulatory Affairs...
-
Director Quantitative Safety Statistician
4 months ago
Dublin, Ireland Novartis Full time1 in 10,000 is the frequency of a rare safety event! The science of detecting, quantifying and communicating adverse drug reactions as well as designing measurable risk minimization activities – this is quantitative safety science. Providing patients with more benefits than risks is Novartis’ top priority.As Director Quantitative Safety Statistician you...
-
Dublin, Ireland recruitNet Full timeRecruitNet International Ltd specializes in relocating qualified professionals throughout Ireland and overseas, we guide you through professional registration, job placement, visa, and employment permit processing. We will provide exceptional patient care in an environment where quality, respect, caring, and compassion are at the center of all we...
-
Dublin, Ireland Beacon Hospital Full timeJob Description Job Title ; PSQI CoordinatorDepartment ; PSQIReports to ; PSQI ManagerDate ; 2024 Overall objective of the positionOur mission is to provide exceptional patient care in an environment where quality, respect, caring and compassion are at the centre of all we do.The overall purpose of the role is to support the overall coordination of the...
-
Assistant Director of Nursing
2 months ago
Dublin, Ireland Agape Global Full timeWe have a fantastic opening for an Assistant Director of Nursing at a reputable Nursing Home.Assist with hiring, training nurses and monitor nursesManaging clinical operations and developing care plansPreparing the daily schedule and planning shiftsEnsuring nursing staff follows departmental procedures and policiesAssisting in budget preparation and...
-
Director – Global Pricing and Market access
1 month ago
Dublin, Ireland EVERSANA Full timeJob DescriptionTHE POSITION: The Associate Principal/Director, Global Pricing and Access, will be responsible for steering project teams in delivering client consultancy projects and managing existing client relationships throughout engagements. This role involves enhancing project managers and related teams with customized insights and strategic guidance....
-
Director, Global Regulatory Affairs, Pediatrics
3 months ago
Dublin, Ireland Gilead Sciences Ireland UC Full timeDescription Director, Global Regulatory Affairs, Pediatrics Dublin, Ireland At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower...
-
Senior Director of Quality Assurance
4 weeks ago
Dublin, Ireland UnitedHealth Group Full timeSenior Director of Quality Assurance - Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...
-
Senior Director of Quality Assurance
4 weeks ago
Dublin, Dublin City, Ireland UnitedHealth Group Full timeSenior Director of Quality Assurance - Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we're one of the world's leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.With a strong ecosystem of investment and...
-
Senior Director of Quality Assurance
4 weeks ago
Dublin, Ireland UnitedHealth Group Full timeSenior Director of Quality Assurance - Dublin or Letterkenny / Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals. With a strong ecosystem of...
-
Senior MSK Physiotherapist
2 months ago
Dublin, Ireland Blackrock Health Hermitage Clinic Full timeAbout the Hermitage ClinicBlackrock Health Hermitage Clinic is a private hospital providing a full range of medical and surgical care across a broad spectrum of specialities. About the roleThe role is responsible for the provision of quality service in line with standards of Physiotherapy practice. As a key member of the frontline management team, the Senior...
-
Dublin, Ireland Cpl Full timeCpl Healthcare is seeking applications for the role of Assistant Director of Nursing for a recently opened 150 bed care centre in South Dublin. This is a full time permanent role where the successful candidate will be responsible for the safe and effective management of patient referrals, facilitating admission and follow through including discharge...
-
Senior Director, Head of External Operations, GEO
4 months ago
Dublin, Ireland BioMarin Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Director, Global Regulatory Affairs, Pediatrics
4 months ago
Dublin, Ireland Gilead Sciences Full timeJob Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...
-
Global Diversity, Equity, Inclusion
11 hours ago
Dublin, Ireland Arcadis Full timeArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36, people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the worlds most complex...