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
Who You Are
You are deeply invested in ensuring the utmost safety for patients involved in clinical trials or using our approved treatments. With the ability to distill complex data into clear, actionable insights, you shine in a collaborative team setting. Your exceptional organization and time-management skills enable you to thrive in a fast-paced environment where your contributions make a significant impact on patient and public health.
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. Safety case processing experience or relevant exposure to PV Scientist tasks preferable.
Preferred Skills - Advanced degree (PhD, MPH, NP, PharmD, etc.)
Job Level: Professional
Additional Information The base compensation range for this role is: $106,000.00-$138,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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.
Job Tags
Full time, Temporary work, Local area