Aggregate Reports PV Scientist
The Aggregate Reports PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team.
* 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.
Essential Skills and Qualifications:
* 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.
* Management and authoring of aggregate data reports.
* Represents and speaks to processes in cross-Safety and cross-functional forums.
* 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.
* Bachelor's Degree in biologic or natural science. Advanced degree (MSc, PhD, MPH, PharmD, etc.) is preferred.
* Minimum 8-10 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports.