Group Head- Medical Safety Operations

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:? Manages and coaches a team of Medical Safety Experts/Specialist/Associates. Manages the strategic planning of the activities delivered by the Medical Safety Experts/Specialist/Associates. Provides strategic leadership within the Medical Safety Operations to ensure compliance in Medical Safety activities and drive compliance and quality to consistently high standards.? Liaises with the Biosimilars/Generics Medical Safety Heads to get feedback on the performance of the Medical Safety Experts and ensures adequate trainings are put in place? Supports Biopharma/Generics Medical Safety Heads for overall training of Medical Safety staff. Develops effective relationships with internal to PS and external stakeholders to ensure successful execution of the Medical Safety expertise.? Accountable for enhancement of operational process (e.g. Signal Management, Periodic reporting, Risk Management Plan) to increase productivity, efficiency and quality in order to achieve Medical Safety Excellence.? Advises and influences the Medical Safety organization on HA regulations and industry practices through close collaboration with Patient Safety and other line functions as well as external forums where Sandoz representation is required? Acts as a subject matter expert during audits and inspections and leads RCA and CAPA actions. Collaborates with External Service Providers to identify and work collaboratively towards addressing evolving needs and ensures effective vendor utilization.? Maintain oversight on the Safety elements of the Integrated Product List and its impact on Patient Safety processes and deliverables; Owns and maintains medical safety processes and ensures that they are up to date and in line with the HA regulations.? Provides guidance on processes to the Countries and regions Patient safety organization as well as other functions outside Medical Safety. Acts as secretary of the Medical Safety Review BoardDiversity & Inclusion / EEONovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum Requirements? Advanced degree or equivalent education/degree in life science/healthcare. MD, MBBS, PharmD, PhD preferred.? 6 years in drug development in a major pharmaceutical company (of which 5 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position); Excellent knowledge of HA regulations and PV processes? Demonstrated people management experience (direct/matrix). Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team.? Demonstrated track record of successful work and management of outsourced activities and proven record of excellent communication skills with vendors.? Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills;? Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure. Quality oriented; Good planning, organizational and computer skills.#orbitWhy 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 whats 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 accommodationNovartis 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 [email protected] 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

Keyskills :