Summary
About the Role
Major accountabilities:
- Exhibit leadership and accountability for Medical Safety (MS) owned/supported processes (and IT systems) by way of regular reviews to identify gaps / issues and/or improvement needs (e.g., optimizations, retirements, automations, etc.) which can be addressed through projects (incl. applicable business case development to succession and correct prioritization); projects should result in improved performance (incl. quality) and/or compliance (considering internal and external/regulatory requirements).
- Exhibit leadership and accountability for initiatives provisioned, led or supported by Medical Safety Operations (MSO) to safeguard deliverables, quality as well as timelines incl. necessary support and course corrections and contingency planning as applicable (e.g., deputy identification and knowledge transition).
- Lead compliance in assigned activities and challenge ‘as-is’ for continuous improvement and assure inspection readiness.
- Lead proactive identification of risks / issues via close monitoring (incl. conductance of effectiveness checks and monitoring of metrics).
- Provide subject matter expertise, guidance & support for process creation and/or updates incl. management of Medical Safety related process issues (both internal and external). This may include providing direct support or arrangement of support from MSO (i.e., through deputy or coordinate with Head P&P for SME identification) as concerns new or ongoing initiatives impacting on processes within Medical Safety and PS&PV (as applicable).
- Support Head MS P&P in strategic and tactical communications related to process changes and other key initiatives as applicable.
- Act as thought partner/coach supporting MS P&P Managers to operationalize their objectives including strengthening their skills, capabilities and overall professional growth.
- Support Head of MS P&P and other MSO Group Leads in creating transparency and sharing key learnings and best practices for continuous improvement (i.e., design, development and delivery of strategy and processes).
- Provide support and/or deputize for Head MS P&P as needed (e.g., in process review board meetings).
- Support readiness preparations for PV Audits/Inspections and provide support during PV Audits/Inspections incl. act as SME where applicable.
- Exhibit accountability for successful integration of M&A to BAU state by providing necessary SME support incl. procuring expert input where necessary.
- Exhibit leadership behavior to foster compliance and to build/nurture strong relationships with internal key stakeholders/customers/partners through exhibiting Novartis values (inspired, curious, unbossed & self-aware) in Medical Safety.
- Ensure completion of applicable trainings in a timely manner.
Minimum Requirement
• Advanced degree or equivalent education in Healthcare / Life Sciences. MD, MBBS, MSc, Pharm D, PhD preferred.
At least 10 years (of at least 5 years in a global role) of project management (at least 5 years as a project leader) and/or Process ownership experience in a pharmaceutical or healthcare consulting setting, preferably in drug safety (i.e., Pharmacovigilance), clinical research, or regulatory affairs (incl. appropriate business case development)
• Solid knowledge in drug safety related processes (incl. authoring procedural documents, workflow design)
• Proven ability to work with large cross-functional teams in complex initiatives
• Results-driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure
• Quality oriented
• Proven ability for clear and concise communication tailored to a diverse audience and effective cross functional collaboration, stakeholder engagement and teamwork
•Very good planning, organizational and computer skills
• Sense of urgency and ability to manage multiple priorities under a changing environment
• Excellent 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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
