As a Senior Vigilance Process Manager, you will be responsible for end-to-end management of assigned pharmacovigilance processes across Novartis and leadership of cross-functional and transformative Patient Safety & Pharmacovigilance (PS&PV) projects to ensure compliance with global regulatory requirements with maximum efficiency.
About the Role
KEY RESPONSIBILITIES
1. Drive continuous process optimization and simplification by aligning relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.
2. Lead/support as a Senior Subject Matter Expert (SME) on complex cross-functional and PS&PV projects, including IT projects/systems, of high priority/criticality to the business.
3. Collaborate closely with the product owner and product team to ensure the product meets required standards and is fit for purpose, providing expertise in process management, risk mitigation, compliance, and continuous improvement.
4. Act as process owner for one or more high-complexity/high-impact vigilance processes within their functional area.
Lead active surveillance and analysis of emerging regulations, perform impact assessments, and drive process changes to ensure ongoing compliance with global regulatory requirements.
1. Analyze the impact of other Novartis processes and organizational changes on assigned processes.
2. Lead the development, communication strategies, and maintenance of procedural documents and training materials.
3. Collaborate with other functions to establish requirements for metrics trend analyses, generate knowledge, and mitigate risks.
4. Serve as SME/consultant to PS&PV associates, country organizations, and other global functions on regulatory requirements and business processes.
5. Own and maintain relevant Pharmacovigilance System Master File (PSMF) sections and annexes.
6. Maintain content of Business Continuity Plans for all respective processes, including IT applications for key business processes.
7. Assume the role of end-to-end process owner when assigned.
8. Act as SME during audits and inspections of the vigilance system (e.g., EMA, FDA), lead response preparation, and develop/implement corrective and preventative actions.
9. Lead collaboration with global functions and third parties to establish and meet joint accountabilities.
10. Lead or act as business representative during mergers and acquisitions.
ESSENTIAL REQUIREMENTS
1. PhD, PharmD, MSc in Life Sciences or equivalent.
2. Fluency in English; knowledge of additional languages is desirable.
3. Minimum 6-8 years of experience in the pharmaceutical industry, especially pharmacovigilance.
4. Leadership and matrix management experience.
5. Ability to lead global, cross-functional teams and initiatives within a matrix environment.
6. Strong organizational, analytical, and project management skills.
7. Excellent negotiation and communication skills; effective in an international, matrix environment.
8. Quality focus.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend lives. We aim to become the most valued and trusted medicines company globally, driven by our people—our associates. Join us in this mission! Learn more about our benefits in the Novartis Life Handbook and our commitment to diversity and inclusion.
If this role isn't suitable but you'd like to stay connected, join the Novartis Network and talent community to hear about future opportunities.
Novartis is dedicated to building an inclusive, diverse work environment that reflects the patients and communities we serve.
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