PV Aggregate Reports Scientist at Myworkdayjobs in Cambridge, MA focuses on About This Role: As a PV Aggregate Reports Scientist, you will be an integral part of the Safety. Your role involves serving as a subject matter expert on aggregate reporting safety requirements worldwide, providing critical insights to the PV Scientist team and cross-functional partners.
About This Role:
As a PV Aggregate Reports Scientist, you will be an integral part of the Safety Surveillance and Aggregate (SSA) Reports team, responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports. Your role involves serving as a subject matter expert on aggregate reporting safety requirements worldwide, providing critical insights to the PV Scientist team and cross-functional partners. You will respond to safety inquiries from both internal and external stakeholders, review and support the authoring of medical and scientific safety information, and work closely with vendors and the vendor oversight team, as well as the Quality Management team, to ensure high-quality standards. Your contributions will also support process improvement initiatives, collaborating with the PV Sciences group and other cross-functional teams to develop and maintain compliant processes that enhance efficiency and lead to consistent work practices across assigned product groups.
What You’ll Do:
- Lead and conduct, independently and/or collaboratively, all aspects of authoring and project management of aggregate safety reports.
- Serve as a subject matter expert on safety requirements and pharmacovigilance activities, representing processes in cross-functional forums.
- Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.
- Conduct worldwide legislation reviews related to aggregate reports and provide impact assessments.
- Assist in authoring responses to safety questions from regulatory authorities in collaboration with stakeholders.
- Contribute to process improvement initiatives and consistency regarding aggregate reports and signal management.
- Support the implementation and maintenance of new and existing processes.
- Interpret, analyze, and present scientific and medical data clearly in both verbal and written formats.
- Collaborate effectively within the team and with external colleagues across Safety, Clinical Development, and other functions.
- Apply clinical judgment to interpret case information and guide staff in interpretation.
Who You Are:
You are someone who thrives in a collaborative environment and brings a strong sense of organization and attention to detail to your work. Your background in pharmacovigilance and your experience with aggregate safety reports equip you to manage complex projects with minimal supervision. You communicate scientific and medical data clearly and effectively, and your ability to interpret and present information is matched by your commitment to maintaining high-quality standards. Your proactive approach to process improvement and your ability to work effectively with cross-functional teams make you a valued contributor to the organization.
Required Skills:
- Bachelor’s Degree in biologic or natural science.
- Minimum 5 years of pharmacovigilance experience, including aggregate safety reports writing and safety signal management.
- Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
- Strong organizational skills and ability to prioritize independently.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
- Knowledge of common safety database systems.
Preferred Skills:
- Advanced degree (MSc, PhD, MPH, PharmD, etc.).
- Advanced understanding of medical concepts and terminology.
- Demonstrated authoring experience within pharmacovigilance.
- Strong collaborative skills within cross-functional teams.
Additional Information
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 Biogen.
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.