Boehringer Ingelheim
Senior Patient Safety Physician - Oncology(m/w/x)
Vollzeit
Senior
Keine Angabe
Ingelheim am Rhein
BO
Boehringer Ingelheim1 Monat
(Senior) Patient Safety Physician(m/w/x)
Vollzeit
Senior
Keine Angabe
Ingelheim am Rhein
Nejo KI-Zusammenfassung
In this role, you will lead and contribute to patient safety and pharmacovigilance activities, ensuring the safety and efficacy of drugs in development and on the market. Your work will involve collaboration across departments, management of safety signals, and development of strategies that prioritize patient health.
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Anforderungen
- •Medical Doctor with clinical or clinical research experience
- •PV experience and good understanding of PV regulations in major markets
- •Experience in clinical development and submissions for marketing authorization
- •Clinical or research experience in cardio-renal-metabolism areas
- •Strong interpersonal and communication skills
- •Strong ethical sense and quality and patient safety mindset
- •Excellent English skills, both written and spoken
- •Extensive experience in PSPV and Risk Management in a pharmaceutical company
- •Very good understanding of the pharmaceutical industry and future trends in pharmacovigilance
- •Thorough understanding of PV regulations in major markets and compliance needs
- •Project management and leadership competencies
Keine Angabe
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Design and implement safety evidence strategies
- •Develop patient-centric risk minimization strategies
- •Plan and manage pharmacovigilance activities for assigned drugs
- •Set up safety analyses in clinical trial databases
- •Continuously monitor and develop product safety profiles
- •Manage safety signals effectively
- •Collaborate with Clinical Development and Global Patient Engagement
- •Work with Global Epidemiology on post-authorization studies
- •Interpret clinical trial safety data for reports
- •Review and provide input on regulatory documents
- •Update senior management on drug safety profiles
- •Recommend pharmacovigilance activities to decision-making committees
- •Chair internal multidisciplinary Asset Benefit Risk Teams
- •Represent Patient Safety and Pharmacovigilance in committees
- •Stay updated on methodology, regulatory changes, and healthcare trends
Sprachen
Englisch – verhandlungssicher
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