Merck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Luzern
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ABAbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Cham
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Independent pharmacovigilance management and Swiss regulatory alignment for a global biopharmaceutical manufacturer. Two years of pharmaceutical PV experience and life-sciences degree required. Direct report management, reporting to Medical Director.
Anforderungen
- Medical, pharmacy, life-sciences degree or equivalent
- Two years' pharmaceutical pharmacovigilance experience
- Scientific acumen and conceptual application skills
- Knowledge of PV activities and systems
- Understanding of Swiss regulatory PV requirements
- Excellent communication and presentation skills
- Fluency in English and German
- French language skills (advantageous)
- High customer orientation
- Commitment to compliance and quality
- Sound judgment and organizational skills
- Strong sense of urgency
Aufgaben
- Report to the Medical Director
- Manage one direct report
- Drive local pharmacovigilance activities independently
- Align affiliate procedures with corporate regulations
- Manage non-conformities and exception processes
- Execute corrective and preventive actions
- Oversee the affiliate PV training plan
- Ensure training compliance for partner staff
- Maintain the adverse event intake system
- Process and translate safety information
- Reconcile spontaneous and solicited safety data
- Partner with Regional PV Teams
- Report individual case safety reports
- Submit periodic and aggregate safety reports
- Develop local safety and PV strategies
- Advise cross-functional partners on safety topics
- Monitor and assess local safety intelligence
- Lead affiliate PV audits and inspections
- Implement safety data exchange agreements
- Identify all local adverse event sources
- Maintain the PV Agreements Database inventory
- Develop specialized PV training materials
- Lead local risk management activities
- Coordinate risk minimization measure distribution
- Monitor medicinal product safety profiles
- Track post-authorization safety study commitments
- Generate and interpret safety evidence
- Communicate safety concerns to Global Teams
- Share safety insights with Medical Teams
- Lead product safety education initiatives
- Assess impact of new PV legislation
- Drive internal and external advocacy efforts
- Engage with local regulatory agencies
Berufserfahrung
2 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – verhandlungssicherFranzösisch – Grundkenntnisse
Tools & Technologien
PV systems
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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.
Noch nicht perfekt?
- Organon
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ABAbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Cham
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Independent pharmacovigilance management and Swiss regulatory alignment for a global biopharmaceutical manufacturer. Two years of pharmaceutical PV experience and life-sciences degree required. Direct report management, reporting to Medical Director.
Anforderungen
- Medical, pharmacy, life-sciences degree or equivalent
- Two years' pharmaceutical pharmacovigilance experience
- Scientific acumen and conceptual application skills
- Knowledge of PV activities and systems
- Understanding of Swiss regulatory PV requirements
- Excellent communication and presentation skills
- Fluency in English and German
- French language skills (advantageous)
- High customer orientation
- Commitment to compliance and quality
- Sound judgment and organizational skills
- Strong sense of urgency
Aufgaben
- Report to the Medical Director
- Manage one direct report
- Drive local pharmacovigilance activities independently
- Align affiliate procedures with corporate regulations
- Manage non-conformities and exception processes
- Execute corrective and preventive actions
- Oversee the affiliate PV training plan
- Ensure training compliance for partner staff
- Maintain the adverse event intake system
- Process and translate safety information
- Reconcile spontaneous and solicited safety data
- Partner with Regional PV Teams
- Report individual case safety reports
- Submit periodic and aggregate safety reports
- Develop local safety and PV strategies
- Advise cross-functional partners on safety topics
- Monitor and assess local safety intelligence
- Lead affiliate PV audits and inspections
- Implement safety data exchange agreements
- Identify all local adverse event sources
- Maintain the PV Agreements Database inventory
- Develop specialized PV training materials
- Lead local risk management activities
- Coordinate risk minimization measure distribution
- Monitor medicinal product safety profiles
- Track post-authorization safety study commitments
- Generate and interpret safety evidence
- Communicate safety concerns to Global Teams
- Share safety insights with Medical Teams
- Lead product safety education initiatives
- Assess impact of new PV legislation
- Drive internal and external advocacy efforts
- Engage with local regulatory agencies
Berufserfahrung
2 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – verhandlungssicherFranzösisch – Grundkenntnisse
Tools & Technologien
PV systems
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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.
Über das Unternehmen
AbbVie
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Noch nicht perfekt?
- Merck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenLuzern - Organon
Medical Science Liaison - Neurology(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenLuzern - Apellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Vollzeitmit HomeofficeSeniorZug - Scholar Rock
Vice President, Medical Affairs, EMEA(m/w/x)
Vollzeitmit HomeofficeSeniorZug - Novartis Pharma Schweiz AG
Key Account Manager Radioligand Therapy (Prostate Cancer)(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenRisch-Rotkreuz