Manager, Drug Safety

Manager, Drug Safety

Biogen

Maidenhead, United Kingdom

About This Role

Joining us as Manager, Drug Safety, you will be responsible for ensuring the end-to-end operation, management, and oversight of local pharmacovigilance (PV) activities. You will play a pivotal role in maintaining compliance with all applicable local and global regulations while acting as a key strategic partner to the business. Additionally, you will provide expert consultation and support for UK and Ireland operations, ensuring that all safety-related processes align with corporate and regulatory standards.

What You’ll Do

• Supervise and monitor outsourced vendors with PV responsibilities;
• Oversee PV-related activities for patient support programs and homecare services;
• Manage the overall provision of safety report handling for the UKI affiliate;
• Act as the local subject matter expert for all post-marketing PV matters;
• Develop, deliver, and track training for UKI employees and external providers on PV-related procedures;
• Maintain a compliant local PV system aligned with Biogen’s Global PV structure;
• Ensure compliance with all programs and contractual arrangements involving adverse event handling;
• Support regulatory requests, audits, and inspections;
• Conduct and track reviews of local literature for safety-related content;
• Assist with late case investigations and oversee PV-related corrective actions and exceptions;
• Compile and submit monthly reports on PV metrics;
• Monitor and assess changes in local regulatory requirements and provide impact assessments.

Who You Are

You are a highly skilled pharmacovigilance professional with a strong understanding of global and local PV regulations. You possess excellent analytical and project management skills, with the ability to work both independently and collaboratively in a fast-paced environment. You have a keen eye for detail and excel in decision-making and organizational tasks, ensuring compliance and operational excellence.

Qualifications

Required Skills

• Bachelor's degree in nursing, pharmacy, or a healthcare-related or life sciences field;
• Significant and proven pharmacovigilance/drug safety experience within the pharmaceutical industry, including experience in a UK & Ireland PV affiliate department;
• Experience with third-party interactions, particularly PV operations vendors;
• Familiarity with Good Pharmacovigilance Practices (GVP), GxP quality systems, and UK & Ireland regulations;
• Prior involvement in audits and regulatory inspections;
• Experience with adverse event intake systems, procedure writing, and training delivery;
• Strong operational and managerial skills demonstrated through leadership of previous projects or functions;
• Strong written and verbal communication skills, including technical writing and documentation;
• Ability to work effectively in a matrixed environment with strong multitasking capabilities.

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