Global Patient Safety Senior Scientist Rare Diseases

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 endeavour 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.

Job Description: 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: The Global Patient Safety Senior Scientist is responsible for:

• Representing Global Patient Safety (GPS) within Global Asset and Clinical Development Teams as the key contact for product safety matters.
• Ensuring robust safety surveillance and integrated safety assessments to support timely updates to safety profiles and risk management actions.
• Proactively managing safety profiles across development and marketed products so safety informs decision-making and milestones are achieved.
• Contributing high-quality input to benefit–risk evaluations; and collaborating closely with assigned Safety teams to support all related activities.

Main Responsibilities:

• Provide scientific review and interpretation of safety data for the preparation of aggregate reports.
• 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.
• Interact collaboratively and effectively in a team environment.
• Understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format.
• Provide scientific expertise to the preparation of responses to internal and external questions relating to the safety of allocated products.
• Deliver efficient and timely review of clinical trial documentation.
• 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.
• 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.
• Liaise with Global Drug Development CROs to ensure that SAE data within the Clinical and Global Patient 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.
• Ensure the timely delivery of accurate information in DSURs and SUSARs to investigators and Ethics Committees.
• Maintain awareness of changes to regulatory guidance documents, requirements and state of the art pharmacovigilance processes.
• Regularly review, update and implement pharmacovigilance business procedures documented in Standard Operating Procedures, guidelines, and user manuals.
• Collaborate closely with manufacturing and Quality Safety Evaluation Board (QSEB).
• Lead a team of safety physicians and safety scientists for assigned products acting as Safety Asset Lead (if required).

Qualifications:

• Bioscience graduate (BSc, BA, PharmD) or Master degree, PhD.
• Extensive pharmacovigilance experience within pharmaceutical industry.
• Working knowledge of pharmacovigilance legislations worldwide.
• Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file.
• Industry experience in clinical development.
• Knowledge of product development processes.
• Fluent in English.

Location: Paris; London (UK)

Type: Full time