PV Governance Lead (m/f/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  42543

 

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:

 

  • Hosting Pharmacovigilance (PV) inspections by competent authorities, PV audits performed by Grünenthal’s business partners and PV audits performed by Grünenthal.
  • Interact with competent authorities, external organizations worldwide, internal departments and Grünenthal subsidiaries, for preparation and resolution of audits & inspections and regulatory intelligence matters.
  • Support auditees with evaluation of audit findings and creation of appropriate corrective and preventive actions for the global GRT PV system.
  • Handling of CAPAs and measurement of their effectiveness, as applicable, maintaining oversight of associated metrics.
  • Steer inspection readiness initiatives in Global Drug Safety
  • Steer the regulatory Intelligence process, monitoring changes in requirements affecting Global Drug Safety processes, being responsible for assigned regions (e.g. EMA, EAEU), interacting with Business Process Owners ensuring accurate assessment for compliant implementation

 

What you'll bring to the table

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

 

  • An university degree
  • Minimum of 5 year experience in Drug Safety, especially with audits, inspections and CAPA management
  • Previous experience with Regulatory Intelligence is preferred
  • Excellent communicative capabilities, interpersonal and influencing skills
  • Excellent project management skills and teamwork abilities
  • Ability to work persistently and in structured manner
  • Ability to work on multiple tasks simultaneously
  • Very good knowledge of English

 

What are some of the local benefits

 

  • Hybrid working model
  • Bilingual daycare centre "Karlinis" and holiday activities for employees' children
  • 30 holidays, plus 6-8 bridging days and possibility to convert salary into up to 5 additional holidays
  • (E-) Bike leasing and e-charging stations

 

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"Join forces with us to maintain and further develop our Global Pharmacovigilance system with focus on audits/inspections, CAPA management and Regulatory Intelligence."

Clara Rosa da Silva Goncalves, the Hiring Manager

 

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: 
Angelika Will

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

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