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Associate Director, Aggregate Reports & Risk Management

Novartis AG

  • East Hanover, NJ
  • 13 days ago

    Highlights

    Major accountabilities: Lead AR&RM operational activities across the product portfolio, ensuring effective coordination, scheduling, assignment, and delivery to Country OrganisationsDevelop and maintain the global aggregate reporting schedule in close collaboration with Country Organisations and global line functions, ensuring timely executionEnsure quality and compliance of aggregate reports, risk management plans, and commitments, including driving investigations, root cause analysis, and CAPA implementationMonitor operational KPIs and lead audit and inspection readiness activities, including Health Authority inspections and regulatory compliance requirementsAct as a key operational interface between AR&RM, Country Organisations, and cross-functional stakeholders to ensure alignment and seamless collaborationRepresent the organisation externally as an operational lead in interactions with relevant stakeholders and partnersDrive operational excellence and lead global PS&PV initiatives to enhance processes, systems, and delivery of AR&RM activitiesLead the transition and integration of new AR&RM activities and support implementation of innovative solutions, including AI-enabled toolsLead onboarding, training, and mentoring of AR&RM associates to strengthen team capability and performanceDeputise for the line manager and support recruitment and team development activitiesEssential Requirements: Degree in Life Sciences, Pharmacy, Medical Sciences, or a related scientific discipline. As Associate Director, Aggregate Reports & Risk Management, you will help run compliant and efficient AR&RM operations, with a focus on operational metrics and compliance, scheduling and assignment, onboarding and training coordination, collaboration across functions and geographies, audit and inspection readiness, operational guidance documents, process updates, and continuous operational excellence.

    Numbers & Facts

    LocationEast Hanover, NJ
    IndustryBiotechnology/Pharmaceuticals
    Company Size10,000 employees or more
    Year Founded1996

    Description

    Job ID

    REQ-10083659

    Jul 17, 2026

    Spain

    Available in: English

    Summary

    Location: Barcelona, SpainWorking Model: Hybrid#LI-Hybrid Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.About this role: Do you want to play a pivotal role in shaping the future of patient safety on a global scale? As Associate Director, Aggregate Reports & Risk Management, you will help run compliant and efficient AR&RM operations, with a focus on operational metrics and compliance, scheduling and assignment, onboarding and training coordination, collaboration across functions and geographies, audit and inspection readiness, operational guidance documents, process updates, and continuous operational excellence.

    About the Role

    Major accountabilities: Lead AR&RM operational activities across the product portfolio, ensuring effective coordination, scheduling, assignment, and delivery to Country OrganisationsDevelop and maintain the global aggregate reporting schedule in close collaboration with Country Organisations and global line functions, ensuring timely executionEnsure quality and compliance of aggregate reports, risk management plans, and commitments, including driving investigations, root cause analysis, and CAPA implementationMonitor operational KPIs and lead audit and inspection readiness activities, including Health Authority inspections and regulatory compliance requirementsAct as a key operational interface between AR&RM, Country Organisations, and cross-functional stakeholders to ensure alignment and seamless collaborationRepresent the organisation externally as an operational lead in interactions with relevant stakeholders and partnersDrive operational excellence and lead global PS&PV initiatives to enhance processes, systems, and delivery of AR&RM activitiesLead the transition and integration of new AR&RM activities and support implementation of innovative solutions, including AI-enabled toolsLead onboarding, training, and mentoring of AR&RM associates to strengthen team capability and performanceDeputise for the line manager and support recruitment and team development activitiesEssential Requirements: Degree in Life Sciences, Pharmacy, Medical Sciences, or a related scientific discipline.Minimum 7 years of experience within the pharmaceutical, biotechnology, or healthcare industry.Proven experience leading complex cross-functional programs, projects, or business transformation initiatives.Intermediate knowledge of pharmacovigilance, drug development, regulatory and business requirements.Demonstrated ability to effectively leverage Artificial Intelligence and digital technologies to enhance decision-making, efficiency, and business outcomes.Proven ability to influence senior stakeholders and build consensus across diverse organizations.Excellent project planning, prioritization, and execution skills with strong attention to detail.Strong communication, collaboration, negotiation, and stakeholder management skills.Experience using project management and collaboration tools, including Microsoft Project, SharePoint, Teams, and Microsoft Office applications.Fluent English - both spoken and written. Additional languages are an advantage.Desirable Skills: Knowledge of Novartis organizational structure, processes, and ways of working.Expertise in project management methodologies such as Lean Six Sigma, Agile, or related approaches.Closing date for applications: 31 July 2026Applications will be reviewed during the week commencing 03 August 2026, and candidates can expect to hear further updates shortly thereafter.Together, we can reimagine medicine. Bring your expertise, leadership, and passion for innovation to Novartis and help create a safer future for patients worldwide. Apply now and become part of our mission!Benefits & RewardsAt Novartis, we''re committed to reimagining medicine together - and rewarding the people who make it happen.Expected Annual Base Salary Range for role: € 63,600 to € 118,000The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies, and experience in accordance with the Novartis pay setting policy and, upon joining Novartis, will be reviewed periodically.In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources, and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.Read our brochure to learn more about our global total rewards offering:Novartis Life HandbookNote: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.Commitment to Diversity & InclusionAt Novartis, we are committed to building an outstanding, inclusive work environment and fostering diverse teams that reflect the patients and communities we serve. We believe that diverse perspectives, experiences, and backgrounds are essential to driving innovation and delivering better outcomes for patients worldwide.Accessibility and Reasonable AccommodationsNovartis is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition, physical disability, or neurodiverse condition, you require a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please let us know. We are committed to ensuring an inclusive and accessible experience for all candidates and will work with you to identify appropriate accommodations.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

    Primary location salary range

    €63,600.00 - €118,000.00

    Division

    Development

    Business Unit

    Development

    Location

    Spain

    Site

    Barcelona Gran Vía

    Company / Legal Entity

    ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

    Functional Area

    Research & Development

    Job Type

    Full time

    Employment Type

    Regular

    Shift Work

    No

    Research & Development Development Spain

    Job ID

    REQ-10083659

    Associate Director, Aggregate Reports & Risk Management

    Apply to Job

    Job ID

    REQ-10083659

    Associate Director, Aggregate Reports & Risk Management

    Apply to Job

    About Company

    Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.

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