Senior Director, Global Patient Safety
3 weeks 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 scientistsTo 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
-
Dublin, Dublin City, Ireland Viatris Company Full timeSenior Director, Global Automation and Manufacturing Systems page is loaded Senior Director, Global Automation and Manufacturing Systems Apply locations Northern Cross, Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R McDermott Laboratories LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act...
-
Dublin, Dublin City, Ireland Viatris Full timeAt VIATRIS, we envision healthcare not only as it currently stands, but as it should be. We act boldly and are uniquely positioned to provide stability in a world where healthcare needs are constantly changing. Viatris empowers individuals globally to lead healthier lives at all stages. We achieve this through: Access – Delivering high-quality trusted...
-
Senior Safety Scientist
3 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeDrug Safety Scientist - Senior Manager - Hybrid/Remote The key focus of the Senior Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and...
-
Senior Safety Scientist
1 month ago
Dublin, Dublin City, Ireland Cpl Full timeDrug Safety Scientist - Senior Manager - Hybrid/Remote The key focus of the Senior Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and...
-
Senior Director, Engineering
3 weeks ago
Dublin, Dublin City, Ireland Edwards Lifesciences Gruppe Full timeWe have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Director, Engineering page is loaded Senior Director, Engineering Apply locations Ireland-Limerick Ireland-Shannon time type Full time posted on Posted 12 Days Ago job requisition id...
-
Senior Director, Engineering
4 weeks ago
Dublin, Dublin City, Ireland Edwards Lifesciences Gruppe Full timeWe have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Director, Engineering page is loaded Senior Director, Engineering Apply locations Ireland-Limerick Ireland-Shannon time type Full time posted on Posted 12 Days Ago job requisition id...
-
Quality and Safety Director
3 weeks ago
Dublin, Dublin City, Ireland Aramark Full timeAt Aramark we're a leading service and solutions provider employing over 6,500 employees right across Ireland. We proudly support clients, partners and customers in food, facilities management, property services, and retail solutions in Business and Industry, Sports and Entertainment, Healthcare, Education and Government sectors.As a leading food service...
-
Dublin, Dublin City, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we envision healthcare as it should be, not as it currently is. We approach challenges with courage and stand out as a pillar of stability in the ever-changing landscape of healthcare. Viatris empowers individuals globally to lead healthier lives at every phase. We achieve this by: Access – Providing high-quality...
-
Global Program Associate Director
3 weeks ago
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare.If you are passionate about Drug...
-
Director, Global Regulatory Affairs, Pediatrics
3 weeks ago
Dublin, Dublin City, Ireland Gilead Sciences, Inc. Full timeDirector, Global Regulatory Affairs, Pediatrics page is loaded Director, Global Regulatory Affairs, Pediatrics Apply locations Ireland - Dublin time type Full time posted on Posted 3 Days Ago job requisition id R For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we're creating a...
-
Clinical Director
3 weeks ago
Dublin, Dublin City, Ireland PE Global Locum Express Full timeJob Opportunity: Consultant Psychiatrist - Clinical Director Location: Dublin - Remote About the role: Collaborate closely with Clinical Directors and Consultant Psychiatrist colleagues. Supervise and implement measures to ensure compliance with regulatory standards and the Mental Health Commission. Provide cover for Clinical Directors & Consultant...
-
Global Director, Financial Business Partnering
3 weeks ago
Dublin, Dublin City, Ireland 110 ICR Ireland - IRE Full timeGlobal Director, Financial Business Partnering page is loaded Global Director, Financial Business Partnering Apply locations Ireland, Dublin time type Full time posted on Posted 11 Days Ago job requisition id JR115269 Job Title: Global Director of Finance (Finance Business Partnering) Location: Leopardstown, Dublin 18 ICON plc is a world-leading...
-
Sr Director, Global Strategic Sourcing
3 weeks ago
Dublin, Dublin City, Ireland West Pharmaceutical Services, Inc Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Title: Sr Director, Global Strategic Sourcing - Devices Requisition ID: 65710 Date: May 3, 2024 Location: Dublin, Leinster, IE Department: Supply Chain Description: At West, we're a dedicated team that is...
-
Clinical Director
3 weeks ago
Dublin, Dublin City, Ireland PE Global Locum Express Full timeI am recruiting for a Consultant Psychiatrist and Clinical Director with a specialism in Forensic Psychiatry.Job Title: Consultant Psychiatrist - Clinical DirectorLocation: Dublin - RemoteAbout the role:Work closely with the Clinical Directors of ID and MH Services and all Consultant Psychiatrist colleagues.Oversee and implement measures to meet regulatory...
-
Global Director, Financial Business Partnering
3 weeks ago
Dublin, Dublin City, Ireland ICON Full timeJob Title: Global Director of Finance (Finance Business Partnering)Location: Leopardstown, Dublin 18 ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health...
-
Assistant Director of Nursing
3 weeks ago
Dublin, Dublin City, Ireland Mowlam Healthcare Full timeMount Carmel Community Hospital is a Transitional Care Unit. This unit provides ongoing medical monitoring, rehabilitation or re-enablement to patients following an acute hospital stay. Mount Carmel Community Hospital provides care and support to assist patients towards their discharge destination.We are now recruiting for an Assistant Director of...
-
Key Account Manager
3 weeks ago
Dublin, Dublin City, Ireland Holland Safety Full time3 weeks ago Be among the first 25 applicants Direct message the job poster from Holland SafetyReporting to the Management Team, this Key Account Management position will play a central role in the continued growth of the company by expanding and strengthening our client base in the key target areas of Pharma, Blue-Chip & Tech sectors. The company's core...
-
Senior Director
3 weeks ago
Dublin, Dublin City, Ireland Gilead Sciences, Inc. Full timeSenior Director - RWE Innovation & External Partnerships Senior Director - RWE Innovation & External Partnerships Ireland - Dublin Pharmacovigilance & Epidemiology Regular Job DescriptionAt 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...
-
Dublin, Dublin City, Ireland PARETO SECURITIES AS Full timeQuality & Patient Safety Administrator (Mental Health Service)Job TitleQuality & Patient Safety AdministratorOrganisationHighfield Healthcare operating Highfield Hospital and Hampstead Clinic Services the 'Approved Centre' registered by the Mental Health Commission.Reporting relationshipThe role reports to the Head of Quality & Patient Safety.Key...
-
Director, Unified Payments
3 weeks ago
Dublin, Dublin City, Ireland Global Payments Full timeAbout Global PaymentsEvery day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and...
