Hobson Prior is seeking a dedicated individual for the role of Medical Safety Operations. This role focuses on ensuring adherence to pharmacovigilance operational processes in assigned projects and collaborating with external service providers. The successful candidate will be instrumental in coordinating the development of study-specific Safety Project Plans and managing the development and submission of Development Safety Update Reports (DSURs).

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Ensure adherence to pharmacovigilance operational processes in assigned projects.
• Collaborate with external service providers to process Individual Case Safety Reports (ICSRs) from clinical trials and ensure expedited reporting requirements are met.
• Coordinate the development of study-specific Safety Project Plans for assigned clinical studies and oversee their execution.
• Manage the development and submission of Development Safety Update Reports (DSURs).
• Ensure compliance with regulatory requirements and timely submission of expedited and periodic reports.
• Oversee the pharmacovigilance part of the electronic Trial Master File (eTMF) in collaboration with Clinical Operations.

Requirements

• Pharmacist, or a Life Sciences degree.
• Experience in a similar position, including working in a structured environment as a member of program/compound teams and in a matrix environment.
• PV inspection experience and leading corrective and preventive actions.
• Experience in leading process improvement within Safety and cross functionally.
• Experience in drug development, in a biotech or pharmaceutical company.
• Experience in a matrix environment, interaction with stakeholder with different background and ability to adapt to corporate culture are essential.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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