Responsibilities would mainly require assisting with the maintenance and publication of the Pharmacovigilance System Master File (PSMF), including but not limited to:

• Serving as the Records Management backup in support of the PSMF
• Setting up the collaboration workspace for PSMF review and edit
• Updating PSMF timelines, as needed
• Drafting PSMF Kick-off slides
• Hosting PSMF Kick-off meetings (Backup to Sr. Manager)
• Capturing Meeting Minutes of the Kick-off meeting
• Updating the PSMF Subject Matter Expert Registry and Outlook Distribution List
• Preparing the PSMF draft for review (Backup to Sr. Manager)
• Resolving comments throughout the PSMF review cycles (collaborative effort with Sr. Manager)
• Publishing the EU and UK PSMFs (collaborative effort with Sr. Manager)
• Supporting ad hoc requests for the PSMF (collaborative effort with Sr. Manager)
• Supporting Summary of PV System (SPS) requests (Backup to Sr. Manager)
• Reviewing and contributing to controlled processes and documented guidances with regard to the maintenance of the PSMF (collaborative effort with Sr. Manager)

• Bachelor’s degree in relevant field preferred (e.g., safety, records management, information management)
• At least 2 years of biotech/pharmaceutical experience, specifically in the areas of interpreting regulations, guidelines, and policies
• Project Management experience
• Communications and training experience
• Ability to interpret records management-related regulations, guidelines and policies - understand where to find and keep up-to-date with new and updated regulations, guidances and policies
• Technology - Strong Microsoft Office skills; Electronic documentation management systems

All your information will be kept confidential according to EEO guidelines.