Job description
Job Description
About This Role
As a Manager, Aggregate Reports Scientist within the Safety Surveillance and Aggregate Reports team of Global Safety and Regulatory Sciences, you will spearhead the end to end management of all aggregate reports, including PSURs, DSURs, PADERs, and local reports. Your expertise in aggregate reporting safety requirements will establish you as a subject matter expert, both within the Pharmacovigilance (PV) Scientist team and across Biogen. You will handle safety inquiries from various stakeholders, contribute to medical and scientific safety information, and engage in vendor and quality management collaborations. Your role is pivotal in driving initiatives for process refinement and ensuring compliance with global PV regulations. By joining our team, you will have the opportunity to contribute to a structure that fosters efficiency and consistency, ultimately enhancing patient safety and product stewardship.
What You’ll Do
- Lead and manage the authoring and project management of aggregate safety reports such as PSURs, DSURs, PADERs, and local reports, both independently and collaboratively.
- Act as a subject matter expert on safety requirements, representing processes in cross-functional forums and advising on company policies/procedures related to PV activities.
- Oversee the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.
- Review global legislation related to aggregate reports and assess their impact on operations.
- Author responses to safety questions from regulatory authorities in collaboration with the PV Scientist team and other stakeholders.
- Drive initiatives aimed at improving process efficiency and consistency in aggregate reporting, signal management, and clinical trial safety oversight.
- Implement and maintain new processes that align with global PV regulations and improve cross-program practices.
Who You Are
You are a strategic thinker with an analytical mind, able to interpret scientific data and medical information with clarity. Your collaborative nature makes you an asset in team environments, and you can effectively engage with colleagues both within and outside the Safety division. With a keen sense of clinical judgment, you can guide others and make informed decisions. You are well-versed in Pharmacovigilance, safety regulations, and possess strong organizational skills. Your proficiency with data processing tools complements your ability to prioritize tasks independently.
Qualifications
This is a Remote position. Must reside in the U.S.A.
- Bachelor’s Degree, preferably in a biologic or natural science. Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
- Minimum of 5 years of Pharmacovigilance experience and 5 years of experience in aggregate safety reports writing and safety signal management.
- Expertise in management and authoring of aggregate data reports.
- Demonstrated ability to understand, interpret, analyze, and present scientific and medical data.
- Proven teamwork capabilities, with effective interaction in a multi-disciplinary environment.
- Clinical judgment skills for guiding staff and interpreting case information.
- Familiarity with clinical trial safety regulations and post-marketing safety regulations.
- Strong organizational skills and the ability to work independently with minimal supervision.
- Proficiency in common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and knowledge of common safety database systems.
Preferred Skills
- Experience in leading cross-functional teams and projects.
- Proven track record of process improvement in a Pharmacovigilance setting.
Additional Information
The base salary range for this position is $113,000 - 151,000. 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.
