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Drug Safety Manager DACH (m/f/d)

Country:  Germany
City:  Stolberg
Department:  Research & Development
Job ID:  43185

 

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:

 

  • Support and deputize LRP-PV DACH (Germany, Austria, Switzerland and Lichtenstein) in Drug Safety Operations, including acting for Germany as deputy Stufenplanbeauftragter §63a AMG and Informationsbeauftragter §74a AMG – Kennzeichnungen, Packungsbeilagen, Fachinformationen
  • Operationally manage the local pharmacovigilance system as well as ensuring patient safety related to local products or where GRT is Marketing Authorisation Holder within DACH Cluster, in close cooperation with responsible Head Office
  • Operationally ensure that all safety information received within the designated territory from all sources are collected, translated and forwarded to Head Office in compliance with required timelines, quality guidelines and internal and external standards
  • Manage local process/standard procedural documents for collecting safety information from a range of sources and working with LRP-PV DACH and Head Office on managing data/topics, including implementation of measures in the territory
  • Ensure PV tasks for any local product are performed to maintain a benefit safety profile (including signal management and risk assessment) in compliance with local legal/regulatory requirements and global standards
  • Monitor safety issues related to Grünenthal products in the reference territory to ensure issues are processed, assessed and reported to all stakeholders (e.g. Authorities, QPPVs, Licensors, Licensees, etc.).
  • Contribute to the oversight of and manage local pharmacovigilance tasks for studies and other organized data collection activities (e.g. clinical trials, market research) in the assigned territories
  • Track and analyse updates in legal and regulatory local/regional PV requirements, including respective communication to relevant internal stakeholders
  • Supports in ensuring the affiliate is GVP inspection-ready, provides support in regulatory authority inspections, business partner or internal audits
  • Manage and conduct PV trainings (onboarding / refresher) to the affiliates in scope or vendor staff according to contracted needs, including ensuring training documentation is in place

 

What you´ll bring to the table

To make the most of this role and truly thrive, you should have:

  • A university degree in medical, pharmaceutical or comparable biological discipline
  • Demonstrated and relevant minimum 1-2 years of experience within PV
  • Experience in supporting a PV system in at least one country within the DACH region, preferably Germany; additional experience in other countries is beneficial
  • A solid working knowledge of local/regional PV relevant guidelines, codes or practice and regulations
  • Fluency in German (preferably mother tongue) and business English language skills
  • Microsoft based and good IT/system competence
  • Strong communication skills
  • Ability to support less experienced colleagues
  • Very structured and attention-to-detail working style
  • Ability to work across a matrix organisation. Flexible, proactive and open working style, supportive of training.
  • Taking ownership and embracing change


 

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

Your HR contact:
Johannes Noel

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal

Apply now »