Director, Safety Systems & Data Analytics - REMOTE

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:

• Development and execution of PPSRM Safety Systems objectives and plans as part of the overall PPSRM process strategy and operational planning.
• Liaison with corporate stakeholders and PVLT to ensure business needs are met and to anticipate future business needs.
• Vendor liaison and relationship management to ensure successful execution of PPSRM process, vision, mission, objectives, and plans.

Requirements:

• MS in technical field strongly preferred; BS in technical field required
• Minimum 10 years in the pharmaceutical industry (ideally in a global organization) with experience in managing drug safety/risk management databases and interface tools, supporting pre- and post-approval products.
• Minimum 5 years of management experience required
• Advanced understanding of core regulations supporting the submission of adverse events for postmarketing and investigational drugs
• Advanced understanding of ICH guidelines
• Working understanding of MedDRA structure
• Strong working knowledge of Oracle databases and PLSQL programming
• Advanced understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements
• Working knowledge of report generation
• Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planning
• Advanced project management skills and ability to influence others
• Advanced knowledge of Global (including US, EU) Pharmacovigilance regulatory requirements and understanding of safety management processes
• Strong strategic, organization, written, analytical and oral communication skills Working knowledge of scientific terms and medical terminology
• Time management and ability to prioritize workload (self, others)
• Quality orientation: attention to detail, accuracy
• Established skills in relational database technology and query (SQL) development.
• Expert level knowledge of:
• Safety Systems administration, gateway support, data collection, report generation.
• Commercial Safety Databases such as Argus Safety and Signaling tools (eg. Empirica, Spotfire)

Requisition ID: 227549

The approximate pay range for this position is $200,000-$220,000. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position. Nestl offers performance-based incentives and a competitive total rewards package, which includes a 401k with Company match, healthcare coverage and a broad range of other benefits. Incentives and/or benefit packages may vary depending on the position.

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestl. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestl seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestl home.

The Nestl Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.