Assoc Director, Patient Safety Medical Device Safety

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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 Gileads medical devices and combination products throughout the product 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 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 Gileads 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 in PV agreements with License Partners.

• 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.

• Develop solutions to a wide range of complex problems ensuring solutions are consistent with organization objectives.

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

• 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.

Basic Qualifications

• BA/BS with 10 years relevant experience OR

• MA/MS/MBA with 8 years relevant experience OR

• PhD/PharmD with 5 years relevant experience

Preferred Qualifications

• Health care professional degree preferably Nursing or Biomedical Engineering degree.

• Extensive medical device / combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities.

• Thorough 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 risk management device vigilance / safety reporting and post-market surveillance preferred.

• Significant experience in navigating a matrix organization.

• Track record of successfully leading complex large scale time-sensitive projects.

• Strong relationship building skills and ability to collaborate influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs.

• Excellent verbal written and interpersonal communication skills. Ability to write clear and concise documents/presentations.

• Ability to prioritize and manage across multiple competing projects.

• When needed ability to travel.

The salary range for this position is:

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.

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