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Global Product Safety Science Lead(m/w/x)
VollzeitRemoteSenior
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NONovartis Pharma AG
Senior Global Program Safety Team Lead - CRM(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading global medical safety teams for CRM therapeutic areas, contributing to benefit-risk evaluations and enhancing scientific expertise. Medical degree or equivalent preferred, with 7+ years in drug development and 5 years in global safety leadership required. Performance-based bonus and long-term equity awards.
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Anforderungen
- Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate health care professional degree
- Specialty Board certification desirable
- At least 7 years progressive experience in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 years in safety at a medical position
- Solid expertise in preparing clinical safety assessments and regulatory reports/submissions involving safety information
- Substantial experience leading cross-functional, multicultural teams
- Strong experience with issue management
- Extensive experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and publication writing
- Strong leadership skills including coaching, motivating, directing, and fostering teamwork
- Ability to develop and maintain effective working relationships with subordinates, superiors, and peers
- Post graduate degree in Pharmaceutical Medicine or Master of Public Health in Epidemiology (or equivalent)
- Strong negotiation and conflict management skills
- Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs
- Cross-Functional Teamwork
- Leadership
- Multicultural Leadership
- Process Safety Management
- Regulatory Compliance
- Safety Science
Aufgaben
- Manage the CRM Therapeutic Area/Development Unit Medical Safety organization
- Provide medical and science-driven contributions to benefit-risk evaluation
- Enhance scientific and clinical experience of Medical Safety physicians/scientists
- Provide continuous training and coaching to Medical Safety associates
- Prepare safety objectives for Medical Safety associates
- Evaluate and manage performance of Medical Safety associates
- Identify talented and high-potential associates
- Discuss associate performance and potential with leadership teams
- Identify career development opportunities with associates
- Support associates in their career paths
- Provide expert safety input to clinical development programs
- Act as a member of Global Program Teams (GPT)
- Act as a member of Global Clinical Teams (GCT)
- Act as a member of Clinical Trial Teams (CTT)
- Manage safety issues from GPT formation through life cycle management
- Oversee signal detection, monitoring, and evaluation
- Interpret and manage safety information from all relevant sources
- Document and track medical safety activities for assigned compounds
- Respond to inquiries from regulatory authorities on safety issues
- Respond to inquiries from healthcare professionals on safety issues
- Lead the preparation of safety strategies for health authority responses
- Collaborate on health authority response strategies with project team members
- Contribute to departmental and business unit goals and objectives
- Lead the development of departmental and business unit goals and objectives
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
NDA submission documentsRMPsPSURs
Benefits
Boni & Prämien
- Performance-based bonus
Attraktive Vergütung
- Long-term equity awards
Sonstige Vorteile
- Insurance plans
- Global recognition programs
Betriebliche Altersvorsorge
- Retirement plans
Mentale Gesundheitsförderung
- Wellbeing resources
Flexibles Arbeiten
- Flexible working options
- Hybrid working options
Großzügige Elternzeit
- 14 weeks paid parental leave
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharma AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Novartis Pharma AGÜber das Unternehmen
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The company is committed to integrating AI-powered tools into drug discovery to enhance data-driven solutions.
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