Novartis
Healthcare
GlobalProgramSafetyTeamLead
Neural analysis suggests this role is
optimal for Lead candidates.
“Global Program Safety Team Lead at Novartis. Skills: Medical Safety, Drug Development, Regulatory Affairs, Team Leadership. Manage disease area within Medical Safety organization. Provide medical and science-driven contribution to Benefit-Risk evaluation”
What You'll Achieve.
Provide impactful medicines to patients worldwide; Achieve excellence in safety strategies; Steer development programs toward breakthrough results
Industry & Context.
Safety issue management; Signal detection; Signal evaluation; Signal interpretation; Management of safety information
What They're Looking For.
Must Have
Medical Degree or equivalent required, PhD, PharmD or equivalent graduate level health care professional degree required, 5 years clinical experience postdoctoral, At least 7 years progressive experience in drug development, 5 years in a global position, 5 years in safety at a medical position, Expertise in preparing clinical safety assessments, Expertise in preparing regulatory reports/submissions, Experience leading cross-functional, multicultural teams, Experience with issue management, Experience in drug development, Experience in clinical trial methodology, Experience in regulatory requirements, Experience in scientific methodology, Experience in statistics, Experience in writing of publication, Leadership skills, Fluent English (spoken and written)
Nice to Have
Specialty Board certification desirable, Post graduate degree in Pharmaceutical Master of Public Health in Epidemiology (or equivalent), Negotiation and conflict management skills, Experience with medical writing, Experience delivering RMPs, Experience delivering PSURs, Additional languages are an advantage
What You'll Do.
Manage disease area within Medical Safety organization
Provide medical and science-driven contribution to Benefit-Risk evaluation
Enhance scientific and clinical experience of Medical Safety
Provide continuous training and coaching
Prepare safety objectives
Evaluate performance of Medical Safety associates
Manage performance of Medical Safety associates
Identify talents and high potential associates
Defend and discuss talent in front of leadership
Identify carrier development opportunities
Support associates in carrier path
Provide expert safety input to clinical development program
Be active member of Global Program Team (GPT)
Be active member of Global Clinical Team (GCT)
Be active member of Clinical Trial Team (CTT)
Manage safety issues from GPT formation through Life
Responsible for overall signal detection
Responsible for signal monitoring
Responsible for signal evaluation
Responsible for signal interpretation
Responsible for management of safety information
Document medical safety activities
Track medical safety activities
Record medical safety activities
Respond to inquiries from regulatory authorities
Respond to inquiries from health care professionals
Lead preparation of safety strategy for health authority
Contribute to departmental goals and objectives
Lead departmental goals and objectives
Contribute to functional business unit goals and objectives
Lead functional business unit goals and objectives
Deputize for Development Unit Head of Neuroscience
How You'll Work.
Team & Collaboration
Cross-functional teams; Multicultural teams; Global Program Team (GPT); Global Clinical Team (GCT); Clinical Trial Team (CTT); Project team members
Communication Scope
Publication writing; Regulatory submissions; Health authority responses; Inquiries from regulatory authorities; Inquiries from health care professionals
Process & Methodology
Issue management, Life Cycle Management
Full Job Description
**Job Description Summary** Step into a career-defining opportunity where your leadership can transform patient outcomes on a global scale! As our Global Program Safety Team Lead in Neuroscience, you’ll be the driving force behind our Medical Safety organization, championing innovative safety strategies and steering our development programs toward breakthrough results. In this pivotal role, your expertise as a safety clinician will empower you to anticipate and navigate complex safety challenges, influence high-stakes decisions, and inspire teams to achieve excellence. Your vision and strategic insight will shape the future of neuroscience safety at Novartis, making a lasting impact for patients worldwide. **Job Description** **Location** : Basel, Switzerland **Working Model:** #LI-Hybrid Hybrid (12 days per month on-site) **Alternate Location** : London (The Westworks), United Kingdom **Working model(s)** : #LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles of our London office) #LI-Remote Remote (if living beyond 50 miles of our London office) **Key Responsibilities:** * Manage an efficient and successful disease area within the Therapeutic Area (TA)/Development Unit (DU) Medical Safety organization, which provides robust medical and science-driven contribution to BenefitRisk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide * Enhance scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching. Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA/DU. Identifies talents and high potential associates and is able to defend and discuss in front of leadership team. Together with associates identifies carrier development opportunities and support associates in the carrier path * Provide expert safety input to the clinical development program for assigned projects/products an
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