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378846BR Job ID: 378846BR Job Description: 100+ process improvement initiatives in Operational Excellence! We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, supporting the organizational strategy while striving for an enhanced productivity, quality and better patient outcomes. Your responsibilities include, but are not limited to: • Lead active surveillance and analysis of emerging regulations and/or leading/supporting the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements • Ensure changes required by new regulations/health authority’s guidance are implemented timely and by the effective date • Leading the development and maintenance of respective procedural documents including ownership of relevant PSMF sections and annexes • Driving continuous process optimization and simplification including opportunities for automation. Develop and implement quality metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate. • Lead projects to optimize methodologies and processes used to monitor safety cases and aggregate reports quality • Assess the impact of any changes to worldwide regulations and/or Novartis group processes on existing metrics and update as required to ensure continued suitability. • Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback into Novartis group standards as appropriate. • Manage assigned monitoring activities / metrics production: Lead investigations into any deficiencies identified, develop, and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these. nnnn Position Title: Vigilance Quality Excellence Manager Minimum requirements: • Minimum 4 to 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable. • Experience in project management and demonstrated ability to lead working groups in a matrix environment • Ability to deal and interact with a wide variety of people at all levels. Strong organizational skills • Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions • Strong analytical skills, Quality focus • Ability to mentor and coach Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: Global Drug Development Business Unit: Patient Safety & Pharmacovigilance Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
