Med. Safety Establ. Medicines Group Lead
- Holzkirchen (near Munich), Germany
- Closing date
- Mar 22, 2023
- Health Sciences, Medicine
- Position Type
- Full Time
- Organization Type
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, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact!This is one such role!
Successfully serves as the scientific and operational safety leader of the Medical Safety Generics Team. To improve patients’ lives and impact on overall Sandoz results through robust safety evaluation expertise and medical innovation.
Ensures optimal delivery of patient safety activities across the Sandoz Generics portfolio, through the effective operational management of the assigned team, oversight of the activities performed by the team, a focus on optimisation of processes and systems to best suit the Sandoz Generics portfolio and effective communications with other functions and leaders.
Takes the lead in developing and improving the processes and systems used by the Sandoz Medical Safety Generics team to ensure compliance, appropriate quality and efficiency, with a “Sandoz generics mind-set”. Lead the effective communication and signal escalations for Sandoz Generics portfolio to relevant internal stakeholders
• Efficiently and successfully manages the Sandoz Generics area within the BioPharma and Generics Medical Safety organization. Enhances operational, scientific and clinical experience of Safety Leads through continuous training and coaching. Leads the performance management process, including preparing safety objectives and evaluating and managing performance.
• Leads the day-to-day safety activities of the Sandoz Generics Medical Safety team. Oversees the assignment of activities within the team and ensures the timely delivery and appropriate quality oversight of Sandoz safety deliverables, including Medical Risk Assessments, PSURs and RMPs
• Responsible for safety issue management across the assigned portfolio, including the overall signal detection, monitoring, evaluation, interpretation, documentation and tracking and appropriate management of safety information.
• In collaboration with the assigned team member, is responsible for responses to inquiries from regulatory authorities and internal stakeholders on safety issues. Support in preparation of safety data for health authority review boards (together with the Sandoz clinical and biostatistical functions). Attends Health Authority meetings, as required.
• Ensures safety information is communicated/escalated to HPS, Sandoz Management and/or EU Qualified Person in a timely fashion.
• Coordinates and presents safety issues to internal Sandoz Boards and other meetings as required. Provides relevant input for SMT and other governance boards as needed.
• Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within other functions, Sandoz Generics (inc Clinical Development, Medical Affairs, Regulatory Affairs) and Sandoz Technical Operations
• Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs), assigned to the role.
• Keeps working instructions / SOPs / GOPs for the area of responsibility up to date with internal (e.g., QMs) and external (e.g., GVP modules) requirements. Works closely with other functions to ensure requirements for generics are represented in safety processes, and with Sandoz Generics functions to ensure PV activities are appropriately represented in Sandoz
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.
• Useful additional degrees: Post graduate degree in Pharmacology, Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent).
• 4 years clinical experience postdoctoral
• At least 7 years progressive experience in medical safety in a major pharmaceutical company, including experience with a generics/ established product portfolio and ideally also originator drug development
• Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
• Strong experience in leading multicultural teams
• Strong experience with (safety or others) issue management
• Strong experience in regulatory requirements, post approval PV methodolgies and product quality assessments
• Strong leadership skills including coaching, motivating, and directing, and fostering teamwork
• Ability to develop and maintain effective working relationships with subordinates, superiors and peers
• Strong negotiation and conflict management skills
• Excellent written and verbal communication skills
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs
• Proven administrative skills including the ability to set and achieve goals, and contribute to the development of departmental strategies
• Good project management and time management skills
• Strong knowledge of global regulatory requirements for safety reporting and labeling
• Previous people management experience preferred
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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