Job Description & How to Apply Below
The Aggregate Reports Senior PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team within Global Safety and Regulatory Sciences (GSRS) and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports) and for associated pharmacovigilance activities for assigned product or group of products, including where required overseeing signal management activities, responses to ad hoc regulatory requests, literature, and clinical trial safety activities.
The Aggregate Reports PV Scientist serves as subject matter expert on aggregate reporting safety requirements worldwide for the PV Scientist team, Safety and Biogen cross-functionally.
Responding to safety questions from internal and external stakeholders, reviewing and supporting with authoring of medical and scientific safety information.
The Aggregate Reports PV Scientist works closely with the vendors and the vendor oversight team, and with the Quality Management team to ensure high quality standards of the PV documents.
Support with initiatives for process improvement, and collaborating 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.
Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead.
Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
Support with process improvement; implements and maintains processes.
Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
In collaboration with PV Scientist lead coordinates and authors responses to safety questions from regulatory authorities.
Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.
Bachelor’s Degree in biologic or natural science or Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred
Strong and proven background working within Pharmacovigilance, including experience in aggregate safety reports writing and safety signal management.
Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Represents and speaks to processes in cross-Safety and cross-functional forums.
Successfully manages substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests performed by direct reports.
Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
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
Strong organizational skills, including the ability to prioritize independently with minimal supervision.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems
Less than 1 Year
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