Assoc Director, Patient Safety Medical Device Safety

Role Summary

Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle. This role includes ensuring compliant global processes for vigilance/safety reporting, post-market surveillance, trending of device complaints, risk management, and analysis of safety data sets covering the portfolio. Drive strategies and ensure operational excellence through business partner collaboration.

Responsibilities

• Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics.
• Review device cases/complaints to ensure accurate case processing and evaluation in compliance with regulatory requirements for safety reporting and internal standards. Collaborate with ICSR and Product Complaint teams to resolve issues between safety and quality databases.
• Develop training and standards for case processing and safety reporting.
• Contribute to Post-Market Surveillance planning and report preparation. Support writing, review, and submission of device contributions in aggregate reports (PSUR/PBRER, PADER).
• Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, as well as device trending and signal management for combination products.
• Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies.
• Collaborate with cross-functional teams in device risk management activities including identification and reduction of risks, conducting benefit-risk analyses, and evaluating residual risk across the product lifecycle.
• Review regulatory intelligence and interpret and update processes regarding device/combination product regulations and updates as required.
• Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally.
• Represent PS in cross-functional working groups regarding device/combination product regulations and their impact to PS.
• Link with PS Alliances team regarding device requirements in PV agreements with License Partners.
• Support internal audits and regulatory inspections; respond and implement corrective and preventive actions for findings on PS processes for medical devices/combination products.
• Develop solutions to complex problems aligned with organizational objectives.
• Foster collaboration and communication to drive business objectives and promote continuous improvement in PS processes and safety oversight.
• Stay abreast of industry trends and best practices in the medical device/combination product space.

Qualifications

• Required: BA/BS with 10+ years‚Äô relevant experience; or MA/MS/MBA with 8+ years‚Äô relevant experience; or PhD/PharmD with 5+ years‚Äô relevant experience.
• Preferred: Health care professional degree (Nursing or Biomedical Engineering) or equivalent; extensive medical device/combination product safety or related experience; experience in pharmacovigilance and device safety activities.
• Deep understanding of medical device/combination product regulations and industry standards globally for design control, risk management, vigilance/safety reporting, and post-market surveillance; ability to translate requirements into safety processes.
• Experience navigating a matrix organization; track record of leading complex, large-scale, time-sensitive projects.
• Strong relationship-building, collaboration, influence, and negotiation skills with cross-functional teams.
• Excellent verbal/written communication; ability to produce clear documents and presentations.
• Ability to prioritize and manage multiple competing projects; travel as needed.

Skills

• Safety oversight and post-market surveillance
• Vigilance/safety reporting and device risk management
• Data analysis and signal management
• Regulatory intelligence interpretation
• Cross-functional collaboration and project leadership

Education

• BA/BS or higher with relevant experience as listed in Qualifications

Additional Requirements

• Travel as needed