PV Aggregate Reports Scientist

Biogen•Cambridge, MA

About The Position

As a PV Aggregate Reports Scientist, you will be part of the Safety Surveillance and Aggregate (SSA) Reports team, managing processes for aggregate reports, including PSURs, DSURs, PADERs, and local reports. You will serve as a subject matter expert on worldwide aggregate reporting safety requirements and provide insights to the PV Scientist team and cross-functional partners. The role includes responding to internal and external safety inquiries, reviewing and supporting the authorship of medical and scientific safety information, and working with vendors, vendor oversight, and Quality Management to ensure high-quality standards. You will support process improvement initiatives with the PV Sciences group and other cross-functional teams to develop and maintain compliant, efficient processes and consistent work practices across assigned product groups. The position requires interpreting and presenting scientific and medical data, applying clinical judgment to case information, and collaborating across Safety, Clinical Development, and other functions.

Requirements

Bachelor’s degree in biologic or natural science.
Minimum 5 years of pharmacovigilance experience, including aggregate safety report 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, including Excel, PowerPoint, Microsoft Word, and Business Objects.
Knowledge of common safety database systems.
Strong attention to detail and ability to manage complex projects with minimal supervision.

Nice To Haves

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.

Responsibilities

Lead and conduct, independently and/or collaboratively, authoring and project management for 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 and consistency initiatives related to 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 verbal and written formats.
Collaborate with the team and external colleagues across Safety, Clinical Development, and other functions.
Apply clinical judgment to interpret case information and guide staff in interpretation.
Respond to safety inquiries from internal and external stakeholders and review and support the authoring of medical and scientific safety information.
Work with vendors, the vendor oversight team, and the Quality Management team to maintain high-quality standards.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
A minimum of 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.