Senior PV Scientist

Senior PV Scientist

Biogen

Maidenhead, United Kingdom

About This Role:

As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role within the Safety team, serving as a product lead for Pharmacovigilance activities. You will be responsible for overseeing and leading safety signal management processes, aggregate reports, and responding to safety inquiries from both internal and external stakeholders. Your expertise will be crucial in reviewing medical and scientific literature for safety information and supporting Clinical Trial PV medical activities. You may collaborate closely with the Associate Director/Director to hire, train, mentor, and manage staff focused on specific products. As a Subject Matter Expert, you will guide Safety and cross-functional teams on global safety regulations, data analyses, and product-specific information. Your contributions will ensure that clinical trials maintain good standing internationally, and that marketed products retain marketing authorization.

What You’ll Do:

• Conduct ongoing safety data reviews and signal detection activities as part of routine pharmacovigilance oversight.
• Lead signal management activities for assigned products, including detection, tracking, documentation, evaluation, authoring signal evaluation reports, and leading Safety Signaling Team meetings.
• Manage literature review activities to identify and assess relevant safety information.
• Oversee aggregate report management, including strategy, review, and finalization of PSURs, DSURs, RMPs, and related safety documents.
• Prepare clear, scientifically robust responses to safety questions from regulatory authorities.
• Collaborate with Global Safety Officers and Safety MDs to support investigational programmes, clinical trial activities, and safety committee management.
• Manage ad hoc safety data analyses and information requests, ensuring timely and accurate outputs.

Who You Are:

You possess a deep understanding of pharmacovigilance with an ability to interpret and communicate scientific and medical data effectively. You thrive in collaborative environments, demonstrating leadership and clinical judgment to navigate complex safety data and regulations. Your strong organizational skills enable you to prioritize tasks independently, ensuring that safety processes are managed efficiently and effectively. You are committed to maintaining high standards and ensuring the integrity of clinical trials and marketed products.

Required Skills:

• Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
• Significant years of pharmacovigilance experience, including aggregate safety reports and safety signal management.
• Proficiency in interpreting, analyzing, and presenting scientific and medical data.
• Strong foundation in pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
• Basic knowledge of common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects) and safety database systems.
• Demonstrated leadership and collaborative skills within team environments.

Preferred Skills:

• Expertise in global safety regulations and guidelines.
• Experience in mentoring and managing staff within pharmacovigilance settings.
• Ability to apply clinical judgment in safety data interpretation.