Job Description

About This Role:

As the PV Scientist Operations and Outsourcing Manager, you will be a vital contributor to the aggregate report team within the Safety Surveillance and Aggregate Report (SSA) group. You will play a crucial role in supporting operational and outsourced activities, focusing on aggregate reports, risk management plans, and signal detection. Your responsibilities will include overseeing multiple vendors, managing daily vendor activities, ensuring inspection readiness, and driving process improvements within the SSA. This position is pivotal to enhancing the operational efficiency and effectiveness of the SSA team, and your efforts will directly contribute to the overall success and compliance of the organization.

What You'll Do:

Engage with and oversee multiple vendors across various roles, including literature, external database mining, signal detection, and aggregate reports. Review and support with developing Scopes of Work and Vendor Relationship Manuals on behalf of the business. Develop training and communication processes to ensure efficient interaction between vendors and Biogen stakeholders, including onboarding processes. Monitor and measure performance using Key Performance Indicators for the vendor and internal team. Build and maintain relationships with vendors and multi-functional teams in different regions. Create new procedures and tools to improve SSA processes and vendor oversight. Lead Inspection Readiness team activities for the SSA team and provide support during inspections and vendor audits. Support with developing safety database FRD/UAT requirements for the SSA team. Manage the SSA SharePoint site. Perform administrative tasks such as maintaining spreadsheets and monitoring email lists and address general SSA questions related to safety database outputs and vendor management. Support Corrective Action and Preventative Action (CAPA) plans and effectiveness checks.

Who You Are:

You are someone who thrives in dynamic environments and brings strong communication and organizational skills to the table. Your ability to prioritize independently and interact effectively within a team setting makes you an asset. You possess a keen understanding of scientific and medical data and can present it clearly both verbally and in written format. Your familiarity with common data processing software and safety regulations showcases your readiness to contribute significantly to the team.

Required Skills:

Bachelor's Degree in biologic or natural science or health care discipline required, Advanced degree such as MSc, PhD, PharmD preferred Strong and proven background and experience working within the pharmaceutical or biotech industries Basic knowledge or experience with outsourcing and vendor oversight. Experience within pharmacovigilance, ideally with aggregate reports, signal detection processes, and/or risk management plans. Strong communication and organizational skills. Ability to collaborate effectively in a team environment. Proficiency in interpreting and presenting scientific and medical data. Basic knowledge of clinical trial and post-marketing safety regulations. Basic knowledge of data processing software (SharePoint, Excel, PowerPoint, Microsoft Word, Business Objects, Safety Data Base [e.g. ArisG, Veeva, Argus]).


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.