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Safety Product Leader (m\/f)

Posted 10 Aug 2018

Darmstadt, Hesse - Germany

Req Id 180294

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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:

As Safety Product Leader for a dedicated Consumer Health product portfolio, you will analyze and integrate complex safety data and deliver high quality documents, such as PBRERs, PSURs, ARs, SBRs, DSURs, pSUSARs, Addendum to Clinical Overviews, Risk Management Plans and updates, Safety Analyses, Expert Statements and other supporting documents for variations and answers to objections.

You will lead and delivery senior expert contributions to proactive pharmacovigilance with rapid identification and analysis of safety signals, benefit-risk evaluations, proactive initiation and efficient implementation of risk minimization measures, and go/no-go decisions at critical development and life-cycle stages for the entire Consumer Health portfolio.

The role includes the delivery of strategic safety expertise to product innovation & development programs as well as post-marketing safety surveillance, to define emerging drug safety profiles for assigned products and drive patient risk management.

As the role provides functional leadership and supervising opportunities (e.g. other team members, vendors and contractors), we are looking for a senior technical expert with an engaged personality and strong capabilities in mentoring, training and motivating people.

Who you are:

  • Degree in medicine or pharmacy - a doctorate would be desirable
  • Minimum of 5-8 years of experience in pharmacovigilance and safety
  • Proficiency in signal detection and evaluation and of continuous Benefit Risk Assessment
  • Proven exceptional data analysis capabilities
  • Excellent communication skills, specifically in written and oral presentations Excellent presentation skills
  • Project management skills and experience with change-management
  • Technology Proficiency: Able to use core MS Office and safety specific applications and proficient in safety database use
  • Future-oriented mindset and high degree of flexibility


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

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