Global Patient Safety Scientist Rare Diseases - FTC/CDD September to May
Paris, Ile-de-France, France · Hybrid
Mid level
Title: Global Patient Safety Scientist Rare Diseases - FTC/CDD September to May Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in t…
Skills: Pharmacovigilance, Safety surveillance, Signal detection, Risk management, Regulatory reporting
Title: Occupational Health Nurse Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease …
Skills: Occupational health nursing, Health surveillance, Spirometry, Audiometry, Vision screening
Title: Global Quality Systems Manager Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Dis…
Title: QC Microbiology Shift Team Leader Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare …
Skills: Microbiology, GMP Compliance, People Leadership, Bioburden Testing, Sterility Testing
Title: QC Micro & Sterility Assurance Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Dis…
Hilltown Township, Pennsylvania, United States · On-site
$60k–$70k/yr
Mid level
Description Ipsen is a Drug Free Workplace Why You'll Love Working With Us: We believe great benefits shouldn't have to wait. That’s why we offer: Day-One Benefits – Enjoy our full benefits package starting your very fir…
Title: Estágio em Qualidade (São Paulo/SP) Company: Beaufour Ipsen Farmaceutica Ltda About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:…
Skills: Quality Assurance, GxP, Documentation, Corrective and Preventive Actions, Change Control
Berkeley Heights, New Jersey, United States · On-site
$250k–$290k/yr
Senior+
Title: Field Medical Director, Neuroscience (East) Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic a…
Skills: People leadership, Strategic planning, Medical science liaison management, Cross-functional collaboration, Thought leader engagement
Director, US Regulatory Advertising & Promotion (Remote)
Cambridge, Massachusetts, United States · Remote OK
$177k–$260k/yr
Senior+
Title: Director, US Regulatory Advertising & Promotion (Remote) Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three …
Skills: Regulatory affairs, FDA advertising and promotion regulations, Promotional review committee, Medical communications, OPDP submissions
Title: Estágio em Procurement (São Paulo/SP) Company: Beaufour Ipsen Farmaceutica Ltda About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic area…
Skills: Procurement, Purchasing, Data Analysis, Excel, Power BI
Berkeley Heights, New Jersey, United States · On-site
$190k–$230k/yr
Mid level
Title: Medical Value Liaison Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare D…
Skills: Health Economics And Outcomes Research (HEOR), Population Health Management, Real-World Evidence, Strategic Account Planning, Medical Communications
Senior Director, Head of Care Pathway Optimization
Cambridge, Massachusetts, United States · On-site
$218k–$315k/yr
Senior+
Title: Senior Director, Head of Care Pathway Optimization Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therap…
Skills: Care pathway optimization, Patient journey mapping, Strategic planning, Health system engagement, Data analytics
Title: Senior Medical Governance Manager Company: Ipsen Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease a…
Skills: Medical Governance, ABPI Code of Practice, Compliance, Medical Affairs, Stakeholder Management
Berkeley Heights, New Jersey, United States · On-site
$161k–$236k/yr
Mid level
Title: Medical Value Liaison Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare D…
Skills: Medical affairs, Health economics, Outcomes research, Strategic account planning, Scientific communication
Title: Senior Manager Prix de transfert Groupe H/F Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncol…
Skills: Transfer pricing, Financial analysis, Tax compliance, Master file, Local files
Description 1 position open $23.41 Ipsen is a Drug Free Workplace Summary Learns all activities required to safely install all components as dictated by design specifications and published schedules, while efficiently ut…
Title: Director, Regulatory Affairs, Labelling Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology,…
Skills: Global Labelling Strategy, Regulatory Affairs, CCDS Development, USPI Oversight, EU SmPC & PIL
Title: Key Account Manager Neuroscience - Nordost (w/m/d) Company: Ipsen Pharma GmbH About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:…
Title: Senior Product Manager Neuroscience (w/m/d) Company: Ipsen Pharma GmbH About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncolo…
Title: Fiscaliste - H/F Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuro…
Skills: Tax strategy, Transfer pricing, French tax law, International taxation, Tax reporting
Global Patient Safety Scientist Rare Diseases - FTC/CDD September to May
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time, Temporary
bachelor degree
Posted 1d ago
~40 hrs/week
Responsibilities
The Global Patient Safety Scientist will conduct safety surveillance, signal detection, and risk evaluation for rare disease products. They will also manage aggregate report preparation and ensure clinical trial safety data compliance across cross-functional teams and external vendors.
Requirements
Candidates must hold a bioscience degree (BSc, BA, or PharmD) and possess relevant experience in pharmacovigilance within the pharmaceutical industry or a regulatory agency. Strong analytical skills and knowledge of pre- and post-marketing PV legislation are essential for this role.
Full job description
Title:
Global Patient Safety Scientist Rare Diseases - FTC/CDD September to May
Company:
Ipsen Pharma (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?
Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
Why Ipsen?
Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
Employee Care: We care for our employees, who are the ambassadors making a real difference.
Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
About the Role: This is a Fixed Term Contract from September to May
The Global Patient Safety Scientist:
Supports the GPS TAs with safety surveillance scientist activities
Interacts with vendors, CROs and business partners as stipulated in the SDEA,
Main Responsibilities
Provide scientific review and interpretation of safety data for the preparation of aggregate reports such as Development Safety Reports (DSURs), Periodic Safety Update Reports (PSURs), etc.; this includes the management and monitoring of vendors used to author such documents
Conduct signal detection activities, signal evaluation and risk assessment, and manage the process for the development and management of Risk Management Plans
Work cross-functionally to ensure that Clinical, Franchise, Asset Team and Regulatory objectives are met by reports being submitted according to international regulatory requirements and Company objectives and timelines. Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Quality, Manufacturing, Clinical Operations and Regulatory), as well as with external colleagues and partners
Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
Provide scientific expertise to the preparation of responses to internal and external questions relating to the safety of allocated products; this includes the management and monitoring of external vendors used to author such documents
Deliver efficient and timely review of clinical trial documentation (protocols, study reports, monthly reports of serious adverse events, TEAEs, AESI etc.)
Provide requisite regular reports of safety data, including appropriate scientific data analysis, to support the MDD and the GPS TAL/Physician in efficient medical monitoring
Review clinical trials safety data throughout the clinical development programme to ensure that any medical issues are raised with the GPS TAL/Physician, and that data meet the quality standards for regulatory requirements
Provide or ensure the provision of an overview of pharmacovigilance definitions and Standard Operating Procedures to study investigators and site monitors at study set-up, and whenever necessary during the running of the trial. In order to ensure that serious adverse events (SAEs) are reported to the Company in a timely and accurate manner and that regulatory safety requirements are understood and met
Liaise with Global Drug Development CROs to ensure that SAE data within the Clinical and Global Patent Safety databases are accurately reconciled in a timely manner for all clinical trials
Liaise with the GPS CRO staff to ensure that they understand their responsibilities for processing data as described in the contract, including contributions to safety data handling plans and other similar documentation, and that SAEs are reported to the Company according to the required timelines
Ensure the timely delivery of accurate information in DSURs and SUSARs to investigators and Ethics Committees, with the generation of periodic line listings
Maintain awareness of changes to regulatory guidance documents, requirements and state of the art pharmacovigilance processes, and make recommendations to improve effectiveness and maintain compliance
Regular review, update and implementation of pharmacovigilance business procedures documented in Standard Operating Procedures, guidelines, and user manuals
Collaborate closely with manufacturing and Quality Safety Evaluation Board
Provide GPS input and collaborate cross-functionally on medical devices and digital media if applicable to allocated products
Provide GPS input and collaborate cross-functionally on Patient Data Collection Systems (like Patient Support Programs and Market Research Programs) and Non Interventional Studies
Qualifications
Bioscience graduate (BSc, BA, PharmD)
Previous experience in a pharmaceutical company
Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files
Awareness of essential pre and post-marketing PV legislation
Proven scientific analytical skills
Experience of pharmacovigilance, either in industry, academia (clinical or public health) or in a health authority
Knowledge of product development processes and experience of cross-functional team work
Knowledge of pharmacovigilance legislation
Fluent in English
#LI-HYBRID
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. Soyons nous-même
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries.
For more information, visit ipsen.com.
Pauta exclusiva para México:
Clave de Autorización COFEPRIS: 243300201B1962
CONSULTE A SU MÉDICO.
Offices: 70, Rue Balard, Paris, Île-de-France 75015, FR · 9 Ash Road North, Wrexham, Wales LL13 9UF, GB · Algeria, DZ · 190 Bath Road, Slough, England SL1 3XE, GB · 1 Main St, Cambridge, Massachusetts 02142, US
PharmaceuticalsSpecialty care: oncologyneuroscienceendocrinologyResearch: peptidestoxinsand Primary CareHealth CareBiotechnologyProduct Research
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries.
For more information, visit ipsen.com.
Pauta exclusiva para México:
Clave de Autorización COFEPRIS: 243300201B1962
CONSULTE A SU MÉDICO.
Offices: 70, Rue Balard, Paris, Île-de-France 75015, FR · 9 Ash Road North, Wrexham, Wales LL13 9UF, GB · Algeria, DZ · 190 Bath Road, Slough, England SL1 3XE, GB · 1 Main St, Cambridge, Massachusetts 02142, US
PharmaceuticalsSpecialty care: oncologyneuroscienceendocrinologyResearch: peptidestoxinsand Primary CareHealth CareBiotechnologyProduct Research