Job Description
About This Role
The Associate PV Scientist serves as a critical team member within the Safety Surveillance and Aggregate Report (SSA) team for products or product groups, including supporting with signal management activities, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, and conducting safety literature reviews. The role will cover activities relating to marketed and/or investigational products.
What You'll Do
Supports Signal Management activities in collaboration with, and oversight from, the PV Scientists:
- Evaluate safety data and conduct signal management activities. This may include updates to signal detection plans, contribution to or authoring of meeting reports, presentations and minutes, and may also include authoring sections of signal evaluation reports.
- Support updates to RMPs
- Collaborate with Global Safety Officers (Safety physicians)
- Represent SSA in cross functional meetings with other departments, such as Regulatory and Clinical Development
- Perform ICF review, AE coding review and other clinical trial safety-related activities
- Conduct literature review
- General administrative tasks (request subject matter experts for information, scheduling of activities, providing information for trackers, requesting database outputs)
Supports Aggregate Report preparation in collaboration with the PV Scientists:
- Supports with the preparation of aggregate safety reports such as PSURs, DSURs
Perform data review and verification:
- Technical and scientific reviews including source data verification
- Editorial review; ensure grammatical and stylistic consistency and accuracy
- Formatting, internal linking, and external cross-referencing
- Support with Quality Checks for documents authored within the SSA team
Qualifications
Required Skills
- Bachelor's Degree in biologic or natural science; or health care discipline.
- Minimum 3 years industry experience with a minimum of 3 years of PV experience.
Preferred Skills
- Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
- Safety case processing experience or relevant exposure to PV Scientist tasks.
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.
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.
