Group Head, Global Aggregate Reports
hace 2 semanas
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. SummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
About the RoleThe Group Head, Global Aggregate Reports & Risk Management leads a group of Senior Global Risk Management Plan Managers as well as Senior Medical Writers and AR&RM Analysts in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high priority products/therapies, aligned with the benefit-risk profile of the products and supported by complex stakeholder matrixes.
Your key responsibilities, but not limited to: Responsible for timely high-quality deliverables either through direct involvement in processes or through assignments taking into consideration individual workload, experience, location, business needs and individual development needs. Interacts with GPTs and Functions (e.g., GPH, HPS, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.Responsible for recruiting, developing, retaining (Sr) Global RMP Managers/(Sr) Medical Writers/AR&RM Analysts, developing and implementing an onboarding program for new hires.Member of the AR&RM Leadership Team. Collaborates with Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.Advises and influences the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes.Guides a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, and working practices.Acts as AR&RM Subject Matter Expert (SME) in inspections and audits.Represents AR&RM in MSRB, GLC, GPTs & SMTs and other relevant boards/teams.Evaluates the impact and ensures compliance in collaboration with OPEX of worldwide regulations and industry practices.Provides input into the development of regular and up-to-date AR & RM training to the organization.Deputizes for the Global Head Aggregate Reports & Risk Management as required.Educational Background: Scientific Degree required. Life sciences degree desirable. Advanced degree (Masters, MD, PharmD or PhD) required.
Languages: Fluent in spoken and written English.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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