VI
Enterprise Client Director at Vidsy selling solutions to transform video advertising for enterprise brands. Collaborating with internal teams to optimize creative production processes.
About the role
- 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 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
Requirements
- BA/BS with 10+ years’ relevant experience OR MA/MS/MBA with 8+ years’ relevant experience OR PhD/PharmD with 5+ years’ relevant experience
- 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.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- benefits package
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
TP
Teva PharmaceuticalsAssociate Director, IT – Value & Access
IT Associate Director supporting Access & Value initiatives in a pharmaceutical company. Delivering technology solutions for payer engagement, pricing strategy, health economics, and outcomes research.
OC
Owens CorningDirector, Employment Law
Director, Employment Law serving as a primary legal advisor for Human Resources at Owens Corning. Managing legal strategies and compliance to enhance business objectives with effective employment practices.
SS
Suntory Global SpiritsDirector, Contract Manufacturing
Director of Contract Manufacturing at Suntory Global Spirits, leading contract manufacturing operations and partner relationships. Focused on delivering quality, cost optimization, and operational excellence.
Area Director of Business Optimization at Waste Management driving operational efficiencies and business solutions. Leading teams and collaborating across various departments in the organization.
Director of Digital Transformation leading strategic improvements through technology and optimization at Zeus Industrial Products. Focusing on efficiency and fostering a culture of continuous improvement.
DR
Digital RealtyDirector, Public Affairs
Director of Public Affairs leading Digital Realty’s government and community relations strategy across the East Region. Collaborating with internal and external stakeholders to achieve public policy objectives.
Regional Vice President leading sales teams in Capital One's Business Cards & Payments group. Responsible for achieving market objectives and developing leaders in the team.
CO
Capital OneBusiness Director – Card Fraud
Business Director managing analysts to develop fraud defenses for Capital One. Driving business strategies and improving customer experiences through data analysis and product development.
DA
Daikin Applied AmericasDirector, Digital M&A – Integrations
Director, Digital M&A overseeing strategy and execution of digital technology acquisitions. Leading integration and collaboration across teams at a top HVAC company with a focus on growth and innovation.