Director, Patient Safety Medical Device Safety

Description

The Patient Safety (PS) department is a global function that is part of the Development organization within Gilead. The main Pharmacovigilance activities of PS are centered at four sites : Foster City-CA, Santa Monica-CA, and Parsippany-NJ in the USA and Cambridge in the UK.

This role sits in the PS Strategic Operations team who are responsible for review of PV-related policies and global regulations, PV Agreements, Distributors, Solicited Programs, operational support of clinical studies, audit and inspection readiness / support, training, ICSR excellence, and Medical Device / Combination Product safety.

Gilead Sciences is seeking a dynamic and experienced individual to join the PS Strategic Operations team as a Director, PS Medical Device Safety responsible for developing and leading implementation of global processes for vigilance / safety reporting, post-market surveillance system, trending of device complaints, and analysis of safety data sets covering Gilead Medical Device and Combination Product portfolio.

This role will drive strategies and ensure operational excellence through successful business partner collaboration.

The Director, PS Medical Device Safety will be a medical device / combination product expert who provides safety oversight and technical contribution 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 strong strategic thinking, communication and analytical skills, a broad PV and Medical Device / Combination Product experience and an enthusiasm for understanding the business needs.

Core responsibilities include, but are not limited to the following :

Provide strategic direction and leadership across PS processes for Medical Device and Combination Product.

Define strategy, develop concepts, and actively implement Medical Device / Combination Product standards for vigilance / safety reporting, post-market surveillance, and trending of device complaints.

Develop and implement global process for vigilance / safety reporting for Medical Device / Combination Product compliant with applicable regulations, standards, and guidelines.

Develop training and standards for case processing and reporting to Health Authorities.

Lead and manage Medical Device / Combination Product Post-Market Surveillance (PMS) system, including PMS system documentation, PMS planning and report management.

Support writing, review, and submission of applicable device contribution in PSUR / PBRER and PADER.

Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to define process for safety assessment of device complaints, as well as trending and signal management for combination products.

Provide device safety oversight and contribution to product development / design control for Drug-Device Combination Products.

Collaborate with cross-functional team in device risk management activities including planning, identification and reduction of risks associated with medical device, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product.

Lead and work with PS cross functional working group to interpret, assess impact and update process and procedures with regards to device / combination product regulations requirements and updates as required.

Collaborate with the PS Affiliate leads regarding local regulation requirements and coordinating globally.

Link with PS PV Alliances team regarding specific device requirements needed in PV agreements with License Partners.

Represent PS in cross functional working groups and teams with regards to Device / Combination Product / IVD regulations and its impact to PS.

Foster a culture of collaboration and communication to drive business objectives.

Collaborate with cross-functional teams in the preparation and / or support of internal audits and regulatory agency inspections;

reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for Medical Device / Combination Product.

Drive a culture of continuous improvement to enhance PS processes and safety oversight. Stay abreast of industry trends, emerging topics, and best practices in the Medical Device / Combination Product space.

Job Skills :

Identifies and pursues global and long-term goals for the group, in collaboration with team head, taking into account and providing support for the strategic goals of the organization.

Demonstrates excellent verbal and written communication skills; has ability to provide direction to a team, and to influence peers and team members appropriately.

Develops solutions to a wide range of complex problems which require the regular use of ingenuity, creativity, and innovation, ensuring solutions are consistent with organization objectives;

develops concepts, techniques, standards, and new applications based on professional principles and theories; viewed as an expert within the organization.

Serves as consultant to PS management in area of expertise and acts as a spokesperson for the PS organization in matters pertaining to its policies, plans, and long-term goals and objectives.

Reviews new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation.

Maintains knowledge of company disease and therapeutic areas.

Recognizes potential or impending problems, implements and delivers solutions.

Contributes to department strategic planning, SOP creation and updates for PS, review and support audits and data analysis pertaining to their projects or the wider PS organization, manages corrective actions and highlights concerns to PS management.

Makes and effects decisions that are long-lasting and influence the future course of the PS organization.

Education and Experience : At a minimum, the ideal candidate will possess

PharmD / PhD with 8+ years’ relevant experience.

MA / MS / MBA with 10+ years’ relevant experience.

BA / BS with 12+ years’ relevant experience.

Practical and demonstrated experience will be considered as part of and / or in addition to formal years of experience.

Extensive medical device / combination product safety or related experience.

Expert understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle.

Experience translating these requirements into medical device safety processes, in particular device vigilance and post-market surveillance preferred.

Previous experience in multiple aspects of pharmacovigilance and device vigilance activities several years and significant experience essential.

Proven abilities to work independently, establishing work priorities and direction, make significant contributions to strategic planning and lead process improvements, as evidenced by past successes effectively managing increasing scope and complexity.

Proven track record of successfully managing large scale, complex, time-sensitive projects.

Interpersonal and communication skills with ability to motivate and influence others.

The salary range for this position is : $201,025.00 - $260,150.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit :

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.