Purpose: This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.    

Responsibilities:  

• Responsible for oversight of surveillance and regulatory activities and deliverables in your designated Therapeutic Area (TA).  

• Leads a team of Safety Data Sciences in their role on the Product Safety Team (PST) within a given TA; contributes to the benefit risk evaluation and to safety risk management.   

• Provide oversight and actively manages full time employee (safety data scientists) and contract support personnel.  

• Key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses.  

• Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures  

• Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile.  

• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plans.   

• Assure deliverable alignment to current company standards and global regulations for products/compounds assigned to direct reports.    

• Leads safety-related activities/initiatives internal to PPS and with external partners.  

• Independently prepares summaries of key safety data for PST, ADT, senior management, Advisory and other similar meetings.   

• Trains new safety scientists and mentors established colleagues.