摘要
Responsible for defining the strategy for Aggregate Reports & Risk Management (AR&RM) in the short and medium term (1 to 5 years) to ensure there is an ongoing cycle of assessment, innovation, and improvement with the aim of achieving high quality deliverables in a cost-effective manner with special attention to implementing automation and ESP solutions. Represents AR&RM in projects of strategic value for the future of PS&PV.
About the Role
Major accountabilities: Responsible for defining the strategy for AR&RM in partnership with the Head AR&RM Office & Strategy and in collaboration with stakeholders from other functions in PS&PV (Medical Safety, Process Excellence and Governance & Risk, QPPV, and others) and Development (RA, GMA, Clinical functions…), and from cross functional boards (GPTs).Responsible for assessing current capacities and capabilities of the AR&RM team and forecasting future needs for short to medium term maintaining the appropriate balance inhouse vs external for cost efficiency and quality.3. Responsible -in collaboration with the concerned team and Process Excellence and Governance & Risk - for exploring initiatives to streamline operations for process and quality improvement. When identified and approved, the person becomes responsible for successful execution of plans4. Responsible for contributing to and leading integration initiatives across aggregate reports (DSUR, PSUR, US PSR), risk management plans (RMPs), and implementation of RMPs in alignment with Development and PS&PV objectives and priorities5. Accountable for exploring new opportunities to develop and promote implementation of Artificial Intelligence solutions and other advanced tools to simplify and facilitate core activities of the AR&RM team. Seeks automation where possible in order to improve efficiency and productivity. This person or a delegate from his/her team will be the point of contact and/or main stakeholder representing the team in any automation project.6. Accountable for establishing close collaboration and alignment with internal PS&PV stakeholders (e.g., Medical Safety, Medical Safety Operations, Countries and Regions, QPPV Office, Process Excellence and Governance & Risk) to ensure their feedback is an important driver for the strategic goals of AR&RM7. Responsible for overseeing and where applicable leading cross-functional forward looking project teams relevant to the AR&RM future in addition to the automation ones described above.8. Support the product categorization list current and communicating internally and externally any changes and their impact.9. Responsible for contributing to BD&L and M&A projects strategy and assignment of SMEs. Acts as the business liaison with the EVE team until assignment takes place.10. Representing AR&RM Operations internally to ensure visibility and alignment with stakeholders and functions external to PVSO and PS&PV11. Supporting AR&RM Office & Strategy Head in recruiting, motivating, developing, and retaining high performing associates to maintain a state-of-the-art organization. Provides regular performance insights of subordinates and supports succession planning as well as their development.12. Representing Novartis externally; participate and/or join external conferences and networks for respective area of expertise.13. Deputizing for the Head of AR&RM Office & Strategy in meetings, boards and during holidays.14. Trains and mentors new AR&RM associates and where required associates from other line functions. Key performance indicators: 1. Champions creative solutions to simplify processes, automate where possible to increase efficiency and productivity2. Cross functional team feedback on effectiveness of alignment of strategies for capabilities, quality of deliverables, process leanness, cost effectiveness3. Value creation of innovative ideas and their execution.4. Adherence to Novartis policy and guidelines5. Escalation of risks to PS&PV leadership and cross-functional boards adequately managed including effective contribution to boards (MSRB, PMC...)6. Successful outcome of pharmacovigilance audits, Health Authorities inspections and Notified Body certification.7. Recruitment, retention, and development of talent in the internal and external team Minimum Requirements: Education and/or professional experience: · Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree · May be an expert within certain project management methodologies, and/or expertise with multiple methodologies (e.g., Lean Six-Sigma, Agile, …)Languages: · Fluent English (oral and written)Experience / ProfessionalRequirements: · Demonstrated track record of success leading large scale cross functional/cross-divisional transformative projects or programs encompassing multiple projects. · At least 8 years in the industry with direct or indirect leadership experience. · Ability to influence and build consensus with senior leaders · Excellent planning and tracking skills with attention to detail including experience with project management tools and systems · Intermediate knowledge of pharmacovigilance processes, drug development processes, regulatory and business requirements of benefit · Enterprise mindset and strategic vision · Negotiation and conflict management skills · Leads with emotional intelligence · Strong interpersonal skills and expert team player with demonstrated ability to build collaborations · Strong verbal and expert written communication skills · Knowledge of software applications (e.g., MS Project, Microsoft Word, PowerPoint, Excel, Office 365 SharePoint, Teams). · Knowledge of Novartis organizational structure and working practices is an advantage.
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Business Unit
Innovative Medicines
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
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