Location: Office (London)
Reporting to: Director, Head of Pharmacovigilance
Job Purpose
To work across a wide range of products to ensure the safety of the use of Orchard Therapeutics (Orchard) products supporting the Head of Pharmacovigilance (PV), 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
- Ensure high quality, accurate, timely scientific contributions to the safety evaluation of OTL products by:
- Leading the preparation of safety data and its scientific interpretation to enable continuous assessment of the benefit risk of use of Orchard products throughout the product life cycle and which drives Company Core Data Sheets, benefit risk assessment and other similar reports.
- Leading the preparation of aggregate reports and responses to Regulatory Agency requests including the preparation and analysis of data.
- Providing data for and review safety components of marketing authorization applications (MAA, BLA and NDA).
- Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department, to include:
- 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.
- Contributing to the development and delivery of training courses for external and internal staff.
- To work cross functionally within project teams to successfully achieve Company objectives and to represent 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
Position Requirements
- 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 pro-active approach and able to work to deadlines.
- Ability to plan and prioritise 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).
Key Competencies specific to the role a
- Enthusiastic
- Desire to grow in the role
- 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
- High focus on detail.
