Pharmacovigilance Scientist

Job Summary:

Orchard Therapeutics is seeking a highly skilled Pharmacovigilance Scientist to join our team. The successful candidate will be responsible for ensuring the safety of the use of our products, supporting the Head of Pharmacovigilance, the Clinical Science team, and all functions to ensure patient safety, compliance with international regulatory requirements, and successful achievement of the Company's objectives.

Key Responsibilities:

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• Leading the preparation of safety data and its scientific interpretation to enable continuous assessment of the benefit risk of use of our products throughout the product life cycle.
  
• Preparing aggregate reports and responses to Regulatory Agency requests, including the preparation and analysis of data.
  
• Maintaining awareness of changes to regulatory guidance documents, requirements, and state-of-the-art pharmacovigilance processes, and making recommendations leading to the improvement of the effectiveness and profile of the department.
  
• Supporting the maintenance of the validated state of the global safety database, leading the maintenance and update of allocated PV Standard Operating Procedures (SOPs), guidelines, and User Manuals, and contributing to the development and delivery of training courses for external and internal staff.
  
• Working cross-functionally within project teams to successfully achieve Company objectives and representing the Department of Pharmacovigilance in a professional and team-oriented manner, while delivering quality and timely input to meet the needs of the project team.
  

Requirements:

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• Pharmacy, medical sciences, or biological sciences degree, or health professional qualification and at least 2 years' experience of working within a Pharmacovigilance Department.
  
• Ability to produce and present high-quality, accurate work both orally and written.
  
• Well-developed time management, communication, and interpersonal skills.
  
• Working knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post-approval environments is desirable.
  
• Responsible, flexible, and accountable with a proactive approach and able to work to deadlines.
  
• Ability to plan and prioritize multi-project workloads.
  
• Fluency in written and spoken English.
  
• Experience in the use and management of Drug Safety Databases and MedDRA coding or desire to learn.
  
• Skilled in Microsoft Office applications (Word, PowerPoint, and Excel).
  
• Enthusiastic and ability to understand the principles of team working and be a member of a high-performing team.
  
• Ability to work under pressure to achieve Company-determined deadlines.
  
• Driving tasks to completion and high focus on detail.
  

What We Offer:

Orchard Therapeutics offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development in a dynamic and innovative company.

How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you.