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Global Patient Safety Physician Rare Diseases

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Ipsen

1mo ago

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • London
  • Quick Apply

AI generated summary

  • You must be a physician with clinical experience in Rare Diseases, expertise in clinical development or pharmacovigilance, regulatory submission experience, strong leadership skills, and fluency in English.
  • You will manage safety surveillance, assess integrated safety information, support benefit-risk decisions, oversee safety profiles, and represent safety in internal and external meetings.

Requirements

  • In order to be considered for this role you must be a physician with proven clinical ability exercising medical judgment as a physician coupled with strong experience in either clinical development or pharmacovigilance ideally in Rare Diseases.
  • Prior experience with FDA/EMA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files or clinical trial applications.
  • You will have exceptional leadership and influencing skills.
  • Fluency in English.

Responsibilities

  • Ensure proactive safety and risk management for all assigned products
  • Accountable for the conduct of safety surveillance and assessment of integrated safety information
  • Support safety decision-making for benefit-risk assessment
  • Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products
  • Act as a member of the Global Product Teams and Clinical Development Teams for one or more products
  • Ensure up-to-date oversight of the emerging safety profile for all TA products
  • Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments
  • Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decisions are made

FAQs

What is the primary focus of the Global Patient Safety Physician role?

The primary focus is to support proactive safety and risk management for assigned products, including safety surveillance, risk assessment, and contributing to safety documents for Rare Diseases.

What qualifications are required for this position?

You must be a physician with proven clinical ability and experience in clinical development or pharmacovigilance, ideally within Rare Diseases.

Is prior regulatory experience necessary for this role?

Yes, prior experience with FDA/EMA regulatory submissions or experience working in a Regulatory Agency is preferred.

What types of skills are essential for this role?

Exceptional leadership and influencing skills, along with strong medical, technical, and scientific expertise in safety data collection and evaluation, are essential.

Will I be working with other teams in this role?

Yes, you will act as a member of the Global Product Teams and Clinical Development Teams for one or more products.

Is fluency in English a requirement for this position?

Yes, fluency in English is required.

What types of activities will I be involved in regarding risk management?

You will support risk management activities for the respective TA products and ensure high-quality safety input for all benefit-risk assessments.

Are there opportunities for career growth within the company?

Yes, Ipsen offers fulfilling challenges and growth opportunities within a fast-moving organization.

How important is collaboration in this role?

Collaboration is very important, as you will need to provide strong safety representation at internal and external meetings where safety decisions are made.

What is the company culture like at Ipsen?

Ipsen values individuals who are bold, agile, and entrepreneurial, focusing on making a sustainable difference in patients’ lives while also caring for their employees.

Manufacturing & Electronics
Industry
5001-10,000
Employees

Mission & Purpose

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries