Medical Director, Global Patient Safety Innovation, TA Immuno-Oncology (all genders)

Posted 01 Jul 2019

Darmstadt, Hesse - Germany

Req Id 191250

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role: The role of the Global Patient Safety Medical Director is to ensure effective proactive medical safety strategies for the assigned development compound(s) and/or marketed product(s) in the field of immuno-oncology; delivery of safety aspects for clinical development; and risk management and benefit-risk evaluation. This includes delivery of the medical evaluation of single safety case reports based on medical judgement and clinical experience; safety signal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation activities, and safety input to clinical trial activities as appropriate.

 

Who you are:

  • Physician with broad clinical experience (several years of medical experience as a physician)
  • Fluent in written and spoken English
  • Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety  decision-making based on clinical acumen and medical judgment)
  • Excellent knowledge of product development process and experience of cross-functional team work.
  • Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
  • Firsthand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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