High Salary Senior Manager, Global Patient Safety
2 weeks ago
Reporting to the Associate Director of Global Patient Safety (GPS), this position is responsible for the initial Intake of adverse event data (i.e., via PV Intake Tool, electronic, fax, etc.). They will lead the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Collaborators and internal destinations in compliance with applicable global regulations (such as ICH-GCP, GVP VI) and contractual obligations. This role will lead a team responsible for Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities, serving as ICSR Submission subject matter expert (SME) on running small to large sized studies/programs that are moderate to sophisticated in scope of work with minimal guidance. In this role, a typical day might include the following: Contributing to Intake responsibilities for Argus events, in addition to all aspects of ICSR submission start-up process Tracking and monitoring of ICSR timelines to ensure that submissions to regulatory agencies, Collaborators, internal destinations and contract research organizations (CROs) are aligned. Proactively investigating potential issues or noncompliance and raises trends and critical issues where appropriate to Management. Leading investigations of non-compliance issues and identification of root cause for late ICSR submissions. Addressing and Implementing appropriate corrective actions related to ICSR submission activities. Assisting in the management and oversight of ICSR transmissions between the PV Intake Tool and Argus database and from Collaborators to Argus database. Proactively identifying and leading continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all deliverables. Authoring new and updates existing SOPs and Working Instructions, and conducts related training. This role might be for you if: You have a minimum of Bachelor's Degree, Master's Degree preferred, in one of the life sciences or clinical research and/or licensed healthcare professional required. Previous experience in drug safety and safety reporting in pharmaceutical/biotech industry is required with minimum of 8 years. Able to independently and expertly identify, analyze, and problem solve complex issues and trends. We are looking for people with strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes. Extensive knowledge of the adverse event lifecycle. Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Director, Global Patient Safety Sciences
24 hours ago
Dublin, Ireland Regeneron Ireland DAC 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...
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▷ High Salary: Senior HEOR Manager
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Dublin, Ireland ICON Clinical Research Limited Full timeGlobal Director, Financial Business Partnering, Dublin 18 ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Global Director...
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Dublin, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
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Dublin, Ireland Beaumont Hospital Full timeOverview Job Title: Senior Speech and Language Therapist ENT/Oncology Post Status: Permanent Department: Speech & Language Therapy Location: Beaumont Hospital, Dublin 9 Reports to: Speech & Language Therapy Manager Salary: Appointment will be made on the Senior Speech & Language Therapist salary scale at a point in line with Government pay policy....
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Dublin, Ireland OASIS Group Full timeDML-01-2025-09 Regional Head of Services Quality and Patient Safety - Dublin, Ireland - Full time, Permanent Who We Are The HSE Dublin and Midlands health region is divided into 4 healthcare areas: HSE Dublin South City and West, HSE Dublin South West, HSE Kildare West Wicklow, HSE Midlands. It will manage and deliver all public health and social care...
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[High Salary] Senior Process Manager
1 week ago
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(High Salary) Project Manager
4 days ago
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High Salary! Senior Project Manager
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▷ [Urgent] Health and Safety Manager
2 days ago
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Regulatory Affairs Senior Specialist
2 weeks ago
Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time Role Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Senior Specialist as we expand. Overall Role...
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Dublin, Ireland Mater Private Hospital Group Full timeSenior Medical Scientist in Biochemistry and Immunology An opportunity has arisen in our Laboratory department for a full-time Senior Medical Scientist in Biochemistry and Immunology. Purpose of the Post: To be responsible for the provision of an efficient, effective, accredited laboratory service for the patients of the Mater Private Hospital. Principal...
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High Salary! Health
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Global Supply Chain Senior Project Manager
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High Salary! Audit Senior
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