Healthcare Businesswomen’s Association
Patient Safety Head US
Healthcare Businesswomen’s Association, Trenton, New Jersey, United States,
Job Description Summary
Posting Title: Patient Safety Head US
About the role:
The Patient Safety Head US is responsible for overseeing the US pharmacovigilance and drug safety operations. This senior executive role involves strategic leadership, regulatory compliance, and operational excellence to ensure the safety of products throughout their lifecycle. The position requires a dynamic leader who can drive innovation, foster a culture of safety, and represent the company at the highest levels both internally and externally.
Your 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.
Role 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.
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.
Commitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
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Posting Title: Patient Safety Head US
About the role:
The Patient Safety Head US is responsible for overseeing the US pharmacovigilance and drug safety operations. This senior executive role involves strategic leadership, regulatory compliance, and operational excellence to ensure the safety of products throughout their lifecycle. The position requires a dynamic leader who can drive innovation, foster a culture of safety, and represent the company at the highest levels both internally and externally.
Your 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.
Role 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.
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.
Commitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
#J-18808-Ljbffr