Global Safety Manager

Job Summary

Responsible for performing adverse event/product complaints correlation analysis and post market surveillance and perform literature and regulatory intelligence review. Prepare and provide metrics for management reviews, as well as data pulls and applicable sections for Global Periodic Aggregate Safety Reports, Device Periodic Safety Update Reports (PSUR), Medical Device Regulation (MDR) and Clinical Evaluation Reports (CER).

Roles and Responsibilities
Key Activities Working under the supervision of the Post Market Surveillance and Trending Lead, the Combination Product & Medical Device Safety Vigilance Specialist will be responsible for: Regulatory Intelligence Review
• Review Regulatory updates from GPS PV Intelligence for impact to Combination Product Safety (CPS). Literature Review
• Perform the review of literature search results for the applicable devices. Post-Product Risk Periodic Review
• Pull data from database review AEs and evaluate any changes to P2 values. External Safety Data Review
• Pull data from MAUDE (FDA Manufacturer and User facility device experience) and FAERs database. Product Complaint (PC) Trending Correlation with Adverse Events (AE)
• Evaluate AEs co-reported with PC excursions identified from monthly PC holistic review to assess impact to patient and user safety (i.e., safety concerns or new harms).
• Reconcile AE lot excursions with PC lot excursions to support PC trending deep dives

Post-marketing Surveillance of Combination Products and Medical Devices
• Pull data to support post marketing surveillance activities for combination products and medical devices. Metrics
• Pull, analyze and provide metrics for various governance forums. Support audits and inspections, as appropriate.

Required Knowledge and Skills:
• Safety experience in biotech or pharmaceutical industry.
• Complaints or complaints trending within a development, manufacturing, or post-market environment.
• Knowledge of product complaints and adverse events intake and processing process.
• Ability to pull and analyse product complaints and/or adverse events data per request.
• Knowledge of medical devices or combination products, including device safety monitoring regulations and standards.
• Very strong knowledge of post market safety reporting regulations for medical devices/combination products globally.
• Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python.
• Excellent interpersonal and teamwork skills.
• Critical scientific thinking and problem solving with attention to detail.
• Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint). Preferred Knowledge and Skills:
• Knowledge of combination products and medical devices, including device safety monitoring regulations and standards.
• Ability to perform data analysis and derive insights.
• Organizational savvy and ability to operate effectively in a matrix environment.
• Prioritization and time management skills.

Basic Qualifications:
• Doctorate degree and 8+ years of Post market surveillance and data analysis experience OR
• Master’s degree or Bachelor’s degree and 9+ years of Post market surveillance and data analysis experience