Job Description Summary The Head of Medical Safety Assessment and External Engagement within Medical Safety Operations, is responsible overseeing the quality of medical review of safety cases in the Novartis Safety system including External Service Providers (ESP). Organize and plan the deliverables of the Medical Safety Experts as per preplanned schedule and ad hoc requests from the Therapeutic Areas, in compliance with Patient Safety business rules. Ensure that the preparation and training of the Medical Safety Experts is provided to a high standard, to deliver activities to the Therapeutic Areas to a high level of quality, timeliness and in a compliant manner. Keeps an oversight of all global vendors/ESPs providing the Medical Safety function with outsourced services across Novartis portfolio. Job Description Key Responsibilities Manage the strategic planning of the activities delivered by the Medical Safety Experts within Medical Safety Operations. Lead and contribute to Medical Safety initiatives as well as cross-functional projects (PS&PV) to optimize medical review processes, oversight and quality. Responsible for Medical Safety outsourcing decisions and assessments. Responsible for managing audit/inspection request pertaining to Medical Review of individual cases. Build a high performing team and recruit, retain and develop the best talent; access resource needs on a regular basis to achieve operational efficiency, to provide SME support towards process excellence and to create/maintain a sustainable compliance culture. Liaise with Head Patient Safety of all Development Units to get feedback on the performance and support of the Medical Safety Experts and ensure adequate training is put in place accordingly. Essential Requirements: Medical Degree or equivalent (preferred), PhD, PharmD Ideally 10 or more years’ experience in drug development including Safety/Pharmacovigilance. At least 3 years of experience in managing medical teams and managing matrix. Excellent negotiation and influencing skills. Ability to mentor, coach associates, and to co-ordinate interactions with internal and external partners. Desirable Requirements: Proven Leadership in creating and developing global safety/ pharmacovigilance teams and lead strategic growth. Ability to work independently, under pressure, meeting tight deadlines, demonstrating high level of initiative and flexibility. Demonstration effective & innovative leadership. Excellent organizational, planning, resource and global project management skills Superior people management skills with demonstrated positive leadership, innovative, and collaborative behaviors. Skills Desired Clinical Research, Clinical Trials, Cross-Functional Teamwork, Leadership, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science, Strategy Development Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Head Medical Safety Assessment and External Engagement.

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