Sobi
Medical Lead Hemophilia(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Basel
SO
Sobi1 Stunde
Global Product Safety Science Lead(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will strategically lead safety science activities for Sobi products, ensuring effective risk management and communication throughout the product lifecycle. You will collaborate with cross-functional teams and mentor junior scientists.
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Anforderungen
- •Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
- •Minimum 8 years of relevant clinical practice, research experience, and/or employment in Drug Regulatory Agency or Pharmaceutical Industry R&D
- •At least 5 years involvement in signal evaluation and benefit/risk assessment of medicines in a global pharmaceutical company or Drug Regulatory Agency
- •Experience leading cross-functional global product safety management teams
- •In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
- •High quality written and spoken English
- •Strong team-leadership capabilities and collaborative skills
- •Sound judgement and ability to assess and handle risks
- •Experience working with partner companies in global markets
- •Experience presenting medical safety information at Health Authority meetings
- •Expertise in various country/regional pharmacovigilance requirements
Master-Abschluss
Berufserfahrung
8 Jahre
Deine Aufgaben
- •Lead the multidisciplinary Benefit Risk Team for signal detection and risk management
- •Represent Safety Science as a subject matter expert in the Medical Development Team
- •Provide clinical safety input for clinical development activities
- •Manage interactions with partner companies regarding clinical safety
- •Develop and implement signal management activities
- •Offer medical and pharmacovigilance expertise for clinical safety strategy
- •Contribute to analysis planning and preparation of product safety documents
- •Lead Safety Science input for post-marketing activities and risk minimization measures
- •Provide safety expertise for regulatory submissions and geo-expansion
- •Support audits and inspections, representing Global Pharmacovigilance
- •Collaborate with cross-functional teams on safety strategies and risk management
- •Stay updated on global regulatory requirements and industry best practices
- •Mentor junior safety scientists within the team
- •Participate in scientific conferences and publications on product safety
- •Develop relationships with key opinion leaders and external experts
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi 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.
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