Summary
About the Role
Key Responsibilities:
1. Strategic Leadership:
- Co-design and lead global and local pharmacovigilance strategies across the ME&A 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.
2. 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.
3. 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.
4. 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.
5. 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.
Key Performance Indicators (KPIs):
- Regulatory Compliance: Adherence to global and local regulatory requirements.
- Operational Efficiency: Reduction in case processing times and increased productivity through process simplification, automation and harmonization.
- Risk Management: Effective identification and mitigation of safety risks.
- Innovation: Implementation of new technologies and innovative practices in pharmacovigilance.
- Team Development: Retention and development of top talent within the pharmacovigilance team.
Minimum Requirements:
Experience:
- 10+ years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical or biotechnology industry.
- 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 companies
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.
Education:
- Advanced degree in life sciences, medicine, pharmacy, or a related field preferred.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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-culture
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
