Head Safety & Benefit Risk Opioids and Generics (m/f/d)

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Lead and develop the organizational unit Safety & Benefit Risk Opioid & Generics within Global Drug Safety and further build the team and develop individual team members
• Plan and track availability of adequate human & technical resources and budget in cooperation with the Head of Global Drug Safety/QPPV and supported by the Corporate Executive Board
• Responsibility for leading and driving safety strategy for assigned Grünenthal’s products; collaboration with appropriate cross-functional departments to ensure efforts are aligned to meet global risk management strategies for the products incl. safety strategies to ensure patient safety and support business in commercialization of the product
• Responsibility for the overall risk management and safety surveillance of assigned Grünenthal’s (investigational) products incl.

         o    Monitoring the safety profile based on all sources and 
         o    Translating this in appropriate safety risk management activities. 

• Delegating accountability for ensuring team manages safety of allocated products according to relevant PV regulations and GRT processes
• Ensuring timely production of key deliverables for team: e.g. signal detection & evaluation; regulatory enquiries; periodic reports & renewals; label creation & maintenance; benefit risk assessment; due diligence activities and Safety Agreement input; risk management activities 
• Acting as Business Process Owner for the Global Periodic Reporting Process (PBRER, DSUR) further develop the process and manage vendors for outsourced documents 
• Support Due Diligence and Post merger integration activities related to medicinal products in collaboration with the lead due diligence and QPPV

What you’ll bring to the table
To make the most of this role and truly thrive, you should have:

• University degree as Physician or advanced university degree and doctorate in pharmacy
• Minimum of 10 years’ experience in pharmacovigilance, thereof 5 years in a global role
• Comprehensive knowledge of the legal & regulatory requirements and standards regarding GVP
• Thorough medical and scientific understanding of drug safety risks and risk mitigation strategies
• Thorough understanding of risk communication
• Experience in Operational Excellence; Customer Focus, Entrepreneurship, Patient Centricity
• Proficiency in building and leading teams
• Very good knowledge of English (both orally and in writing)