Sobi
Global Quality GVP Manager(m/w/x)
Vollzeit
Senior
Keine Angabe
Basel
SO
Sobi3 Tage
Global Product Safety Scientist(m/w/x)
Vollzeit
Berufserfahren
Data Science
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will work closely with the Global Product Safety Science Lead to shape the Safety Science strategy for Sobi products. Your day-to-day responsibilities will involve collaborating with multidisciplinary teams, preparing safety reports, and ensuring compliance with regulatory standards.
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Anforderungen
- •University level qualification in biosciences, healthcare, or pharmacy
- •Minimum 3 years' post-graduation experience in pharmaceutical industry
- •Advanced knowledge of pharmacovigilance regulations
- •Excellent written and spoken English
- •Strong analytical and problem-solving skills
- •Effective communication and team leadership capabilities
- •Experience in process development, implementation, and oversight
- •Proven delivery within a matrix safety team
- •Problem solver with a proven delivery focus
- •Effective team player
Bachelor-Abschluss
ODER
Doktor / Ph.D.
Berufserfahrung
3 Jahre
Deine Aufgaben
- •Collaborate with the Global Product Safety Science Lead to develop and implement the Safety Science strategy for assigned products
- •Contribute to the operation of the product level multidisciplinary Benefit Risk Team, including signal detection and risk management
- •Provide clinical safety input to study teams, potentially serving as study level Safety Lead
- •Support the creation and maintenance of core and EU Risk Management Plans
- •Lead the preparation of periodic safety reports and contribute to benefit-risk assessments
- •Monitor and evaluate incoming safety information to identify potential safety signals
- •Contribute to regulatory submissions and product safety information in various documents
- •Liaise with external service providers to ensure strategic alignment and timely delivery of Safety Science documents
- •Support product-specific case management guidance and respond to medical safety inquiries
- •Participate in literature reviews and contribute to worldwide literature review strategies
- •Support audits and inspections related to product safety
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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