Summary
About the Role
Major Accountabilities:
- Lead and oversee day-to-day MSA & EE operations, ensuring timely and high-quality delivery of all assigned safety and operational activities.
- Drive compliance, inspection readiness, and adherence to global pharmacovigilance regulations, quality standards, and internal procedures.
- Act as deputy for Group Leads when required, including governance participation, MRQC arbitration, decision-making, and operational oversight.
- Provide leadership and accountability for strategic initiatives, ensuring deliverables, timelines, quality outcomes, risk mitigation, and business continuity planning.
- Lead and support safety deliverables for PVA 3 and PVA 4 compounds, ensuring effective execution and stakeholder alignment.
- Identify, drive, and implement continuous process improvements to enhance efficiency, quality, compliance, and operational excellence across safety activities.
- Proactively monitor performance metrics, identify risks and issues, conduct effectiveness checks, and implement corrective actions to ensure sustained operational effectiveness.
- Support pharmacovigilance audits and inspections by contributing to inspection readiness activities, serving as a Subject Matter Expert (SME), and addressing audit findings.
- Collaborate with external service providers (ESPs) and cross-functional stakeholders through governance forums, training, communication, and performance management activities.
- Partner with PS&PV Quality and Clinical Quality teams to implement Quality Plans and ensure timely closure and tracking of all CAPAs arising from audits, inspections, and quality reviews.
Minimum Requirements
- Advanced degree in Healthcare/Life Sciences preferred (MD, MBBS, MSc, PharmD, PhD) with fluency in written and spoken English.
- Minimum 10 years of experience in Drug Safety, Pharmacovigilance (PV) Operations, and/or Project Management.
- Strong expertise in drug safety processes, including procedural documentation, workflow design, and operational excellence.
- Proven ability to lead and collaborate with large cross-functional teams in complex, global initiatives.
- Results-oriented professional with a proactive, accountable, and quality-focused approach, capable of working effectively under pressure.
- Excellent communication, stakeholder management, planning, organizational, and computer skills, with the ability to manage multiple priorities in a dynamic environment.
- Demonstrated leadership capabilities, including mentoring, negotiation, conflict resolution, decision-making, problem-solving, and presentation 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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
