Aggregate Report PV Scientist

The Aggregate Reports PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports).

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 closly 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.

Key Responsibilities:

• 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 Qualificatiosn Required:

• 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.)
• Minimum 8- 10 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports

If you believe you can be a good fit, please contact me directly:

Alba Jansa: alba.jansa(at)experis.ch / Whatsapp: +41 76 811 63 99