Global Patient Safety Scientist Rare Diseases - FTC/CDD September to May

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!

For more information, visit us at https://www.ipsen.com/   and follow our latest news on LinkedIn and Instagram .

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: 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

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