Patient Safety Head US

2 weeks ago


East Hanover, New Jersey, United States Novartis Group Companies Full time

Job Summary:

We are seeking a highly experienced and skilled Patient Safety Head US to lead our pharmacovigilance and drug safety operations in the US. As a senior executive, you will be responsible for overseeing the safety of our products throughout their lifecycle, ensuring regulatory compliance, and driving innovation in pharmacovigilance.

Key Responsibilities:

  • Strategic Leadership:
    • Co-design and lead global and local pharmacovigilance strategies across the US organization.
    • Lead the development of safety policies and procedures to ensure regulatory compliance.
    • Provide strategic direction to ensure proactive risk management and mitigation.
    • Represent the company as a key opinion leader in external scientific, regulatory, and industry forums.
  • Operational Management:
    • Oversee the collection, evaluation, and reporting of adverse event data from clinical trials and post-marketing sources.
    • Ensure robust safety signal detection, risk assessment, and management processes.
    • Lead cross-functional teams to address safety issues and implement risk minimization strategies.
    • Optimize pharmacovigilance systems and processes through continuous improvement initiatives.
  • Regulatory Compliance:
    • Ensure compliance with global, regional, and local pharmacovigilance regulations and guidelines.
    • Maintain up-to-date knowledge of evolving regulatory requirements and industry best practices.
    • Interface with regulatory authorities and external partners to discuss safety profiles and risk management plans.
  • Talent and Team Development:
    • Lead, mentor, and develop a high-performing pharmacovigilance team.
    • Promote a culture of continuous learning and professional development.
    • Foster collaboration and knowledge sharing within the team and across the organization.
  • Innovation and Technology:
    • Drive the adoption of advanced technologies and automation to enhance pharmacovigilance operations.
    • Identify and implement innovative approaches to safety data collection and analysis.
    • Collaborate with IT and data science teams to leverage big data and artificial intelligence in pharmacovigilance.

Requirements:

  • 10+ years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical or biotechnology industry.
  • Advanced degree in life sciences, medicine, pharmacy, or a related field preferred.
  • Experience with global pharmacovigilance regulations and compliance.
  • Proven track record in leading and managing large, diverse teams.
  • Significant experience in strategic leadership roles within a multinational pharma company.

Skills:

  • Expertise in pharmacovigilance processes, risk management, and regulatory requirements.
  • Ability to cultivate high-performing teams and lead through change.
  • Ability to manage and influence stakeholders, as well as represent the organization internally and externally.
  • Ability to drive innovation and implement advanced technologies.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and interpersonal skills.

About Novartis:

Novartis is a global healthcare company that is committed to helping people with diseases and their families. We are a community of smart, passionate people who collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives.

Benefits and Rewards:

Novartis offers a comprehensive benefits package that includes medical, financial, and paid time off benefits, as well as opportunities for professional development and growth.

Commitment to Diversity & Inclusion:

Novartis is committed to building diverse teams, representative of the patients and communities we serve, and strives to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Salary Range:

The pay range for this position at commencement of employment is expected to be between $257,600-$386,400.



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