Job Summary
The Aggregate Reports PV Scientist is a critical role within the Safety Surveillance and Aggregate (SSA) Reports team, responsible for overseeing the processes associated with all aggregate reports (PSURs, DSURs, PADERs, and local reports). This individual serves as a subject matter expert on aggregate reporting safety requirements worldwide for the PV Scientist team, Safety, and Biogen cross-functionally.
This role involves responding to safety questions from internal and external stakeholders, reviewing, and supporting the authoring of medical and scientific safety information. The Aggregate Reports PV Scientist works closely with vendors and the vendor oversight team, as well as the Quality Management team, to ensure high-quality standards of the PV documents.
The successful candidate will support initiatives for process improvement and collaborate with the PV Scientist group, other Safety Staff, and cross-functional groups to develop, implement, and maintain processes that are compliant with global PV regulations, improve efficiency, and lead to consistent work processes across assigned product groups taking into account cross-program practices.
Key Responsibilities:
* Project Management and Authoring: Manage and author aggregate safety reports such as PSURs, DSURs, PADERs, and local reports in collaboration with the PV Scientist Lead.
* Subject Matter Expertise: Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
* Process Improvement: Support process improvement; implement and maintain processes.
* Aggregate Reports Master Schedule and Worldwide Legislation Overview: Be responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
* Regulatory Authority Responses: In collaboration with the PV Scientist lead, coordinate and authors responses to safety questions from regulatory authorities.
* Process Improvement Initiatives: Contribute to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management, and responding to ad hoc safety questions.
Essential Skills and Qualifications:
* Scientific and Medical Data Analysis: Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
* Collaboration and Teamwork: Interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
* Aggregate Data Reporting: Manage and author aggregate data reports.
* Representative and Communicator: Represent and speak to processes in cross-Safety and cross-functional forums.
* Pharmacovigilance Knowledge: Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
* Organizational Skills: Strong organizational skills, including the ability to prioritize independently with minimal supervision.
* Data Processing Software: Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
* Education and Experience: Bachelor's Degree in biologic or natural science; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred. Minimum 8-10 years of Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports.