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.

• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices).
• Familiarity with clinical development process.
• Demonstrating high case level productivity and quality.
• Attention to detail.
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR
• Masters degree and 7 years of Drug Safety or Life Sciences experience OR
• Bachelors degree and 9 years of Drug Safety or Life Sciences experience.

• Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry.
• Bachelors 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)