About This Role:
As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a pivotal role in ensuring the safety and efficacy of our products while fostering a collaborative and high-performing team environment. Your role involves leading pharmacovigilance activities for specific products, providing strategic direction and scientific oversight. You will oversee signal detection, manage the creation and review of aggregate reports, and lead the development of Risk Management Plans (RMPs). Responding to regulatory requests and ensuring comprehensive safety surveillance are key components of your responsibilities. This position is crucial to maintaining high standards of patient safety and compliance with global PV regulations. You will drive operational efficiencies, foster cross-functional collaboration, and contribute to organizational projects and goals, ensuring our safety surveillance practices are innovative and aligned with best practices.
This is a hybrid role, with 50% of each week to be spent on site at our offices in Maidenhead.
What You’ll Do:
Serve as the lead PV Scientist for designated products, providing strategic direction and scientific oversight.
Oversee signal detection and management activities to ensure product safety.
Support the creation and review of aggregate reports such as DSURs, PBRERs, and PADERs.
Lead the development of Risk Management Plans.
Respond to regulatory requests and conduct literature reviews for comprehensive safety surveillance.
Oversee clinical trial safety activities to maintain high standards of patient safety.
Ensure strict compliance with global PV regulations and drive operational efficiencies.
Lead and coordinate key departmental initiatives to advance strategic goals.
Foster cross-functional collaboration to drive innovation and improvement in PV practices.
Develop and implement initiatives to enhance team capabilities and operational workflows.
Represent the department in cross-functional meetings and contribute to organizational projects.
Mentor team members, ensuring adherence to global PV regulations.
Who You Are:
You are a strategic thinker with a strong background in pharmacovigilance and a passion for ensuring product safety. Your collaborative nature allows you to effectively foster cross-functional relationships and drive innovation within a team environment. You possess excellent organizational skills and are adept at prioritizing tasks independently with minimal supervision. Your ability to mentor others and lead initiatives makes you a valuable asset to the team, and your expertise in safety surveillance ensures comprehensive oversight and execution of PV functions.
Required Skills:
Bachelor’s Degree in biologic or natural science, and/or Advanced degree (MSc, PhD, MPH, PharmD, etc.).
Extensive and proven years of pharmacovigilance experience, including safety signal management and aggregate safety reports writing in both clinical trial setting and post-marketing.
Experience in authoring and leading safety sections for Global Filings (e.g. US NDA, EU MAA), including authoring and leading the EU Risk Management Plan
Experience in authoring signal evaluation or analysis, authoring (safety) Risk Management Plans (RMPs – core and EU) and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
Interacts collaboratively and effectively in a team environment.
Subject matter expertise in pharmacovigilance and drug development.
Experience in mentoring others and leading PV Scientists in decision-making impacted by PV and drug development requirements.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Knowledge of common safety database systems.
Knowledge of case processing, expedited reporting rules, and safety database concepts.
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 Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Biogen Maidenhead, England Office
Maidenhead, United Kingdom
