Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können

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  • Munich, Bayern, Deutschland CorpFin Search GmbH Vollzeit

    Job OverviewWe are looking for a seasoned Associate Director to become a vital part of our client's legal M&A division. In this role, you will play a key part in delivering legal expertise for M&A activities, which includes performing comprehensive legal due diligence, formulating and negotiating Share Purchase Agreements, and providing guidance on Warranty...

  • Regional Director

    Vor 2 Tagen


    Munich, Bayern, Deutschland Mantell Associates Vollzeit

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Associate Director

vor 2 Monaten


Munich, Bayern, Deutschland ageneo Life Science Experts GmbH Vollzeit
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Über uns

For a globally leading (bio)pharmaceutical company, we are assigned to recruit an Associate Director Patient Safety Physician (gn) for the therapeutic area Inflammation. Your primary focus will revolve around orchestrating the global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development. In this role, you will work closely with the clinical development department and will be involved in a very strategic and global function.

Aufgaben
  • Crafting proactive, patient-centric RM strategies tailored to designated compounds.
  • Overseeing and executing all PV activities pertinent to assigned drugs, encompassing database setup, continual safety monitoring, and addressing safety concerns.
  • Engaging in cross-functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient-centric benefit-risk evaluations for developmental compounds.
  • Collaborating with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
  • Analyzing clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
  • Providing medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
  • Keeping senior management apprised of the safety profile of designated drugs and suggesting PV/RM actions
Profil
  • Medical degree with clinical and/or clinical research experience.
  • Proficient knowledge in pharmacovigilance (PV) and a comprehensive understanding of PV regulations in major markets.
  • Experience in clinical development and involvement in regulatory submissions would be advantageous.
  • Clinical or research experience in the therapeutic area inflammation are a big plus.
  • Strong interpersonal and communication skills.
  • Strong ethical sense coupled with a focus on quality and patient safety.
  • Excellent English language skills, both written and verbal.
Wir bieten
  • highly strategic and development-related role
  • high-impact on the development of new drugs
  • global and intercultural work environment
Kontakt

Sollte diese Position Ihr Interesse geweckt haben, freue ich mich auf Ihre Kontaktaufnahme und ein erstes Kennenlernen. Ihre Beraterin für diese Position ist Frau Dilsâd Babayigit. Bitte schicken Sie Ihren aktuellen Lebenslauf per Mail an oder kontaktieren Sie mich gerne per Telefon unter der Rufnummer