Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it\'s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.

Your responsibilities include, but are not limited to:

• Advises and influences the organization on RMP policy and processes, including industry practices of implementation and compliance through close collaboration with Patient Safety and other line functions in Sandoz, Sandoz companies and third parties, to optimize the risk management plan system within Sandoz.
• Maintain and oversee an internal and external network for intelligence activities to influence safety regulatory policy
• Lead initiatives to develop, implement and manage state-of-the-art processes, methodology and to support the development, implementation, and compliance with global risk management plans.
• Develop and maintain SOPs, KPIs, quality standards and associated monitoring tools to ensure compliance and quality management of global risk management plans, including review and providing RMP related input in other Line function SOPs as relevant.
• Designs, develops and maintains metrics to monitor quality of RMPs, and escalates to QPPV, Patient Safety leadership and cross-functional boards any potential risk and issues
• Manage a system for tracking and monitoring risk management plans and their component object and tools to identify areas for improvement and compliance, including advising and influencing within and outside Patient Safety on tools for related RMP activities.
• Leads as a key contact, RMP related matters in audits and inspections at Sandoz for global RMP set-up and provides leadership for RMP related Corrective and Preventative actions.
• Lead the development and implementation of training programs for global and local relevant line functions within Sandoz on risk management plan processes, tools, and compliance.

Minimum requirements

• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required. Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) desirable.
• Fluent in spoken and written English. Relevant experience (e.g., clinical, postdoctoral) after graduation. At least 5 years in drug safety, clinical re-search, or regulatory affairs, post marketing in a major pharmaceutical company, including 3 years expert knowledge in safety risk management is desirable.
• Proven ability to work with large cross-functional teams in complex projects, including new submissions and post marketing medicines. Has demonstrated teamwork and effective communication skills. Proven ability to partner with other line functions and establishing effective relationships with stakeholders at all levels
• Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.
• Proven ability to interpret, discuss efficacy and safety data relating to multiple therapeutic area. Solid Medical/Scientific writing and verbal skills.
• Experience in MedDRA and post marketing safety signal detection; Experience with (safety or others) issue management and decision making on safety topics. Experience with PV audits and inspections and writing and implementation of CAPA

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Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 achieve here at Sandoz!

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Group 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

Functional Area

Research & Development

Division

Operations

Business Unit

NTO SANDOZ TECHOPS

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis