Global Patient Safety Scientist

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Paristime type:
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R-19756**Title:**Global Patient Safety Scientist**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 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!For more information, visit us at and follow our latest news on and .**Job Description:**Ipsen is a dynamic and 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 and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.We offer employees a wealth of fulfilling challenges and growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.As **Global Patient Safety Scientist** in **Neuroscience** you will:* Support the GPS TAs with safety surveillance scientist activities including scientific analyses, case reviews, data reviews and presentations, study team membership, clinical safety, supporting phase I – IV + Patient Support Programs, Market research Programs, signal management and risk assessment activities.* Interact with vendors, CROs and business partners as stipulated in the SDEA, evaluation of product quality issues and emerging safety issues.* Author or contribute to safety documents, aggregate reports, RMPs and health authority requests and interactions for allocated projects/products**Main Responsibilities**:* Provide scientific review and interpretation of safety data for aggregate reports (e.g., DSURs, PSURs), including oversight of vendors responsible for authoring these documents.* Lead signal detection, evaluation, and risk assessment activities, and manage the development and maintenance of Risk Management Plans.* Collaborate cross-functionally to ensure Clinical, Franchise, Asset Team, and Regulatory goals are met, with timely and compliant report submissions. Engage effectively with internal teams (Safety, Clinical Development, Medical Affairs, Quality, Manufacturing, Clinical Operations, Regulatory) and external partners.In order to be considered for this role you must have:* Bioscience diploma (BSc, PharmD, M.D.)* **Strong experience of pharmacovigilance, either in industry, academia (clinical or public health) or in a health authority*** **Working experience of product development processes and experience of cross-functional team work*** Awareness of pre- and post-marketing PV legislation* **Experience of safety issues related to known target organ toxicities** (e.g. hepatic, renal, hematologic)* **English fluency.**#LI-HYBRIDIPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.### Get In TouchIntroduce yourself to our recruiters and we''ll get in touch if there''s a role that seems like a good ..... full job details .....