ITM Isotope Technologies Munich SE
Senior Manager, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSenior
Garching bei München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ITITM Isotope Technologies Munich SE
(Senior) Director, Head of Global Drug Safety(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global drug safety leadership for targeted radiopharmaceuticals in oncology. 12+ years' pharmacovigilance experience with oncology drug development expertise required. Flexible hours, home office options, and attractive special payments.
Anforderungen
- MD, PharmD, or PhD in Medicine, Pharmacy, Life Sciences, or related scientific discipline
- More than 12 years of progressive Pharmacovigilance/Drug Safety experience
- Strong oncology drug development expertise
- Proven experience in clinical development and post-marketing pharmacovigilance
- In-depth knowledge of global pharmacovigilance regulations and reporting requirements
- Success in small- to mid-sized biotech environment with hands-on, strategic leadership
- Fluent German and English, written and spoken
Aufgaben
- Lead global pharmacovigilance strategy
- Align strategy with corporate and development goals
- Provide senior leadership for benefit-risk evaluation
- Strengthen pharmacovigilance infrastructure
- Maintain scalable systems and processes
- Ensure compliance and organizational growth
- Provide medical oversight of safety data
- Review and interpret ICSRs
- Detect and manage safety signals
- Conduct aggregate safety data analysis
- Lead signal evaluation and risk management
- Assess and mitigate safety risks
- Support development and regulatory decisions
- Oversee end-to-end pharmacovigilance activities
- Ensure robust safety surveillance
- Deliver high-quality safety reports
- Ensure compliance with global regulations
- Maintain inspection readiness
- Provide strategic safety support for regulatory submissions
- Interact with regulatory authorities and health agencies
- Provide expert safety leadership
- Optimize pharmacovigilance operations
- Oversee case processing
- Manage vendor/CRO relationships
- Monitor KPIs and quality
- Mentor and develop safety team
- Collaborate with Clinical Development
- Work with Regulatory Affairs
- Engage with Medical Affairs
- Integrate safety strategy across programs
- Represent Drug Safety in governance forums
- Participate in safety review committees
- Contribute to executive leadership discussions
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Weiterbildungsangebote
- Comprehensive onboarding programme
- Individually tailored further training programme
- German and English courses
Flexibles Arbeiten
- Flexible working hours
- Home office options
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Above-average contribution to company pension scheme
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Gemeinnützige Ausrichtung
- Sponsorship of sporting events
Mentoring & Coaching
- Lifestyle coaching sessions
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ITM Isotope Technologies Munich SE 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- ITM Isotope Technologies Munich SEHead of Clinical Operations(m/w/x)Vollzeitmit HomeofficeSeniorGarching bei München
- CatalYmSenior Safety Physician(m/w/x)Vollzeit/Teilzeitmit HomeofficeSeniorMünchen
- ITM Isotope Technologies Munich SEHead of Purchasing(m/w/x)Vollzeitmit HomeofficeSeniorGarching bei München
- ITM Isotope Technologies Munich SELead Clinical Research Associate(m/w/x)Vollzeitmit HomeofficeSeniorGarching bei München