About This Role
As the International Pharmacovigilance (IPV) Excellence Lead, you will be at the forefront of ensuring high standards of pharmacovigilance practices across operations globally. Positioned within the IPV team, this role is pivotal in identifying and resolving issues proactively, thereby minimizing risks and enhancing compliance. With a hands-on approach, you'll spearhead continuous improvement initiatives, contributing your expertise as a subject matter expert. Your efforts will be instrumental in optimizing operational efficiency and ensuring compliance, positioning this role as a key driver in our commitment to safety and quality in drug safety practices. You will collaborate with various stakeholders, providing guidance and fostering an environment of shared best practices within the global network.
What You’ll Do
- Contribute to overseeing and updating training materials for case handling procedures to ensure effective global AE collection.
- Coordinate the lifecycle management of IPV controlled documents, including SOPs and R&D Business Processes.
- Implement measures to monitor compliance and enhance quality in local PV procedures and operations.
- Connect with Safety Designated Staff at affiliates to identify and address barriers to execution.
- Present data to leadership, proposing process improvements and training updates.
- Review audit trends, communicate findings, and highlight common risk areas.
- Drive procedural changes with process owners to resolve issues and harmonize IPV processes.
- Collaborate with quality organizations to update on audit observations and remediation plans.
- Support regional and local technology needs harmonization and optimization.
- Ensure optimal use of Affiliate PV Operations Vendors and alignment with global strategies.
- Foster a culture of sharing best practices and innovations within the affiliate network.
- Maintain tools and materials to support affiliate audits and improve efficiency.
- Produce core materials for affiliates to present to local leadership on PV compliance.
- Manage improvement initiatives, collaborating with co-leads and SMEs to drive projects to completion.
Who You Are
You are a strategic thinker with a deep understanding of pharmacovigilance regulations, and you thrive in dynamic environments. Your communication skills, both written and verbal, are exceptional, enabling you to convey complex information clearly. You possess the ability to adapt and work independently or collaboratively, demonstrating a goal-oriented mindset. Your attention to detail and accuracy is impeccable, and you excel in multi-tasking and prioritizing tasks effectively. Analytical and decisive, you are ready to lead initiatives that will have a significant impact on our global operations.
Required Skills
- Strong and proven experience in drug safety/pharmacovigilance in a pharmaceutical setting.
- In-depth knowledge of Global, Regional, and Local PV regulations and requirements.
- Excellent written and verbal communication skills.
- Well-developed technical writing and presentation skills.
- Strong project management capabilities.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to work effectively in a fast-paced, matrixed environment.
- Self-starter with strong decision-making and analytical skills.
- Minimum of a bachelor’s degree in pharmacy, medicine, or a relevant life science.
- Experience interacting with third parties such as PV operations vendors.
- Knowledge of Good PV Practices.
- Experience with Adverse Events Intake systems and writing procedures.
- Proficiency in English and local language if not native.
Preferred Skills
- Direct experience in GxP compliant quality systems.
- Experience with audits and regulatory inspections.
Job Level: Management
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.
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.
