Global Patient Scientist, Rare Diseases - CDD

Global Patient Scientist, Rare Diseases - CDD

Ipsen Pharma

Boulogne or Les Ulis, France

Job Description:

The Global Patient Safety (GPS), Safety Scientist is a key member of the Rare Disease team, reporting to the Therapeutic Area Head - Rare Diseases. As the GPS Safety Scientist, you support the GPS Therapeutic Area with safety surveillance scientist activities including scientific analyses, case reviews, data reviews & presentations, study team membership, clinical safety.

In this role your primary focus will be:

• 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.
• 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
• 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
• 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
• Collaborate closely with manufacturing and Quality Safety Evaluation Board

In order to be considered for this role you will have a relevant qualification coupled with a proven track record in pharmacovigilance, ideally in Rare Disease and have experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files. You will have experience with safety issues and be a strong and committed team player, both operationally and strategically. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

The role will initially be based in Boulogne or Les Ulis Courtaboeuf.

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