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 & 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 & 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.
