Job Description

The Clinical Trial Safety Manager will be responsible for supporting the Pharmacovigilance (PV) operations of pre- and post-approval clinical studies globally. They will actively participate as a member of the Study Management Team and perform PV activities including but not limited to: present at Kick Off Meetings, create and finalize protocol specific safety worksheets, review safety language in protocols, create protocol specific training materials, request protocol specific safety database setup, and liaise with stakeholders as required to ensure PV operations study start-up activities are completed.

WHAT YOU’LL DO

• Ensure safety report collection standards and processes are implemented and executed consistently throughout pre- and post-approval clinical studies globally.
• Support partner/vendor Clinical Trial safety report collection and collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives.
• Contribute to the development, maintenance and implementation of: controlled documents (SOPs), data handling conventions and other process documents for clinical trials and post-marketing clinical studies; safety operational content and processes for clinical trial and post-marketing clinical study tools for report collection such as protocols, CRFs, SAE forms, pregnancy forms; tools and processes for database requirements and configurations to enable safety-related activities during studies; training requirements and materials for clinical trial safety report collection.
• Update safety forms and templates and other Clinical Trial Safety related documentation as needed
• Support the Clinical Trial Safety team with ad hoc needs as they arise.

WHO YOU ARE

You're an experienced PV professional well versed in clinical trials. You have strong organizational skills and can successfully collaborate across various functions. 

Qualifications

• Bachelor's degree required with a minimum of 5 years pharmacovigilance and GCP experience (experience may be gained concurrently)
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Knowledge of case processing and handling of ICSRs
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology
• Proven ability to handle multiple projects and priorities simultaneously with effective results

Additional Information

WHY BIOGEN?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.