Assoc Director, Patient Safety Medical Device Safety

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an 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. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration.

The Associate Director, PS Medical Device Safety will be a medical device / combination product expert who supports safety oversight and provides technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance and trending / signal management for medical devices and combination products worldwide. The role would suit someone with passion for patient safety, strong strategic thinking, communication and analytical skills, broad PV and medical device / combination product experience and an enthusiasm for understanding the business needs.

Key Responsibilities

Responsibilities include, but are not limited to:

• 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 that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database.

• Develop training and standards for case processing and safety reporting.

• Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation.  Support writing, review, and submission of applicable device contribution 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 team in device risk management activities including identification and reduction of risks associated with Gilead’s medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product.

• Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required.

• Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally.

• Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS.

• Link with PS Alliances team regarding device requirements needed i