Case Management – Specialist (Device Safety)

• Support interactions with business partners (license partners) and vendors for all case intake and processing activities
• Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures
• Ensure vendor compliance with approved processes and training requirements
• Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors
• Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
• Provide audit & external inspection support
• Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases
• Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements
• Provide vendors with resources and training to perform their role
• Responsible for raise of device/combination product case related issues
• Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products
• Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
• May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
• Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor
• Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
• Ensures compliance and timely reporting with device/combination product cases through query process
• Contributes to the implementation of new intake-related systems, processes and procedures within the process
• Supports an engaging culture
• Ensures quality of PC, AE and OSF records
• Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems
• Implements Standard Operating Procedure requirements for device/combination product cases
• Develops solutions to technical problems up to moderate complexity

• Doctorate degree and 4 years of Drug Safety or Life Sciences experience
• Master’s degree and 7 years of Drug Safety or Life Sciences experience
• Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience
• Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
• Bachelor’s Degree in a health-care subject area or scientific field
• Previous experience with a corporate intake system or safety database
• Ability to successfully manage workload to strict timelines
• Familiarity with basic project management tools
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices)

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards