Director, Safety Systems & Data Analytics - REMOTE

Director, Safety Systems Support And Data Analytics

As a leader in the science of nutrition, Nestl Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life, Nature's Bounty, Vital Proteins, Nuun, Persona Nutrition, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

The Director, Safety Systems Support and Data Analytics will be accountable for implementation, development and maintenance of the Global Safety Database(s) and other technical solutions to assist the Pharma Patient Safety and Risk Management staff in the medical and regulatory oversight of global pharmacovigilance activities of Nestl Health Science investigational and marketed products.

Responsibilities :

• Act as the primary liaison with Safety Operations personnel and vendors for safety database systems maintenance and support
• Act as primary liaison with IT to coordinate delivery, maintenance and validation of safety systems infrastructure
• Collaborate proactively with internal stakeholders and vendors to determine appropriate departmental and company solutions for management, extraction and analysis of safety data.
• Contract negotiation and coordination of external vendors to implement and support software as a service and other technical solutions required by PPSRM end users to ensure appropriate data capture and management, regulatory compliance and robust safety management activities.
• Work collaboratively with other groups (e.g., IT validation, Quality Systems Validation) to implement vendor system solutions and ensure systems meet regulatory standards
• Sets objectives and manages resources for multiple projects of moderate to high complexity; participates with senior management in establishing strategies and projects; administers timelines and performance measures to achieve short- and long-term objectives for department
• Proposes future directions using innovative technologies derived from understanding of multiple professional areas; encourages innovation and fosters an environment for development and application of new methodologies
• Oversee the development and maintenance of SOPs relevant to the safety systems infrastructure and support the development of procedures for operational activities that involve the safety systems
• Ensure support and education on Safety and Analytics systems for end users
• Oversee quality, accurate programming of complex queries and reports on demand as well as standard reports to be provided on a scheduled basis to stakeholders.
• Responsible for oversight of the generation of formal reports, summaries and listings in support of medical monitoring, signal detection and aggregate reporting deliverables (PBRER, DSUR)
• SME in audits and regulatory inspections and ensuring inspection readiness at all times
• Development of metrics and data for signaling, compliance and departmental KPI's & QPI's

Strategy Development and Execution :

Requirements :