Head of Medical Safety GCSP

Head of Medical Safety GCSP

Planegg Vollzeit 100000 - 130000 € / Jahr (geschätzt) Kein Homeoffice möglich
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Auf einen Blick

  • Aufgaben: Leite ein Team von Sicherheitsexperten und entwickle innovative Sicherheitsstrategien.
  • Unternehmen: Wachsendes Unternehmen im Bereich klinische Sicherheit und Pharmakovigilanz.
  • Vorteile: Einzigartige Möglichkeit, Einfluss auf die öffentliche Gesundheit zu nehmen und Karriere zu fördern.
  • Weitere Informationen: Arbeiten in einem internationalen Team mit flexiblen Reiseoptionen.
  • Warum dieser Job: Gestalte die Zukunft der Patientensicherheit in einem dynamischen, wissenschaftlich orientierten Umfeld.
  • Qualifikationen: MD-Abschluss und über 10 Jahre Erfahrung in klinischer Sicherheit erforderlich.

Das prognostizierte Gehalt liegt zwischen 100000 - 130000 € pro Jahr.

About the Role Head of Medical Safety GCSP – responsible for all medical safety related aspects of clinical safety and pharmacovigilance across Global Clinical Safety & Pharmacovigilance (GCSP).

The position reports to the Head GCSP & EU/UK QPPV and can be based in either Germany or Switzerland; travel up to ~20% within Europe is expected.

Key Responsibilities Lead and develop the medical safety team of six (Sr) Safety Physicians and (Sr) Safety Scientists.

Ensure high quality clinical safety contributions to development programs and life‑cycle management of marketed products in compliance with regulations, guidelines and SOPs.

Serve as a member of the GCSP Leadership Team and in governance committees as assigned.

Ensure medical safety support for GCP and GVP audits and inspections.

Contribute to company strategic initiatives and innovations.

Stay abreast of innovative technologies, tools, and regulations concerning area of expertise.

Address ad‑hoc safety issues and lead innovation projects in your area of expertise.

Qualifications Medical Doctor (MD) degree combined with leadership experience in clinical safety and pharmacovigilance.10+ years of experience in clinical safety and pharmacovigilance, including senior Medical Safety roles.

Deep regulatory expertise across global safety activities, including signal management and risk minimization.

Solid knowledge of global clinical safety and pharmacovigilance regulations (GCP, GVP, ICH guidelines) and hands‑on experience in CTD compilation and MAA/BLA submissions to major health authorities.

Fluency in English with strong written, verbal and presentation skills using medical and regulatory terminology.

Proficiency in relevant IT tools and database applications.

Proven ability to mentor, motivate and sustain high‑performance teams.

Strong ethical stakeholder engagement, decision‑making and resilience in a fast‑moving life‑science environment.

Advanced degree is required; an MD qualification is mandatory.

Benefits & Impact Map a unique opportunity to take end‑to‑end responsibility for medical safety activities within a science‑driven organization.

Mentor a high‑performance team, work closely with global stakeholders, contribute directly to regulatory submissions and patient safety, and shape risk‑management activities.

Gain a platform to make a lasting impact on public health and advance the mission of a global vaccine company.

Application Qualified candidates may apply directly.

The position does not include relocation support.

Head‑hunters or recruitment agencies are requested to refrain from contacting us regarding this role.

Equal Opportunity Employer Bavarian Nordic is an Equal Opportunity Employer.

All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr

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Kontaktdaten:

Bavarian Nordic GmbH Recruiting-Team

Wir glauben, dass du diese Fähigkeiten brauchst, um Head of Medical Safety GCSP mit Bravour zu bestehen

Facharzt für Medizin (MD)
Leitungserfahrung im Bereich klinische Sicherheit und Pharmakovigilanz
Regulatorische Expertise in globalen Sicherheitsaktivitäten
Signalmanagement
Risikominimierung
Kenntnisse der globalen klinischen Sicherheits- und Pharmakovigilanzvorschriften (GCP, GVP, ICH-Richtlinien)
Erfahrung in der CTD-Zusammenstellung und MAA/BLA-Einreichungen