Pharmacovigilance Specialist

Neu-Isenburg, Germany
Job Description

As pharmacovigilance specialist your overall responsibility is to keep patients at the heart of what we do by ensuring the continuity of all PV activities in Germany. This role is a critical point of contact for the local regulatory authority on all safety matters and for our internal stakeholders. 

To become a success in this role, it is crucial you are great to collaborate and able to condense and simplify complex topics. Follow the strategic direction for Global Safety Regions including the establishment and maintenance of globally and when needed locally standardized practices, to ensure compliance with international and national regulations. 

You will be supporting the corporate business strategy into tactical short- and long-term strategies acknowledging local obligations and strategies. 



  • Fulfill the role and responsibilities of Deputy Safety Contact Person
  • Prepare and conduct PV training of local LEO Pharma employees, non-PV staff incl. external service providers
  • Document and process adverse event and other experience information from solicited and spontaneous reports including basic case entry for all local pharmacovigilance cases and ensure data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases
  • Support audit & inspections
  • Ensure reporting of SUSARs from interventional clinical trials including DSUR to authorities and ethic committees
  • Ensure that a PV agreement is in place (where relevant) for local initiated PSP, MR and social media activities and keep informed about IIS.
  • Participate in Global Safety projects
Desired Skills & Experience
  • You have a strong and proven track record with Pharmacovigilance and its deliverables. Your strong systematic mindset allows you to solve problems. Importantly, you are self-driven and ambitious, and it is crucial that you are great to collaborate. 

    To succeed in this role, we imagine that you have the following qualifications: 

    • Bachelor's degree or academic degree in natural sciences, preferably with experience in pharmacovigilance of 4 years (post-marketing and clinical trials)
    • Good knowledge of local and EU PV regulations
    • Have strong command of English and German, written and spoken

    This is a hybrid position with the opportunity of working from home at least 2 days per week. 
Leo Pharma
New York