Clinical Trial Safety Manager

Job Description

• 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

Qualifications

Experience:
• Minimum of 5 years of pharmacovigilance and GCP experience required (experienced may be gained concurrently)
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Knowledge on 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 required
• Proven ability to handle multiple projects and priorities simultaneously with effective results

Education
• Requires a minimum of a Bachelor’s degree in a healthcare professional degree (e.g. nursing, pharmacy)



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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