Manager, Drug Safety

Job Description

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.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.