Detail

Salary
negotiable
Location
Neu-Isenburg, Germany
Posted by: Leo Pharma
14 Mar
268 Views
13 May EXPIRED

Pharmacovigilance Specialist

Neu-Isenburg, Germany
Job Description

LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you.  

You can play a significant role in making this vision come true as you will be a key player in driving the pharmacovigilance agenda in Germany together with the Global LEO Pharma PV community. 

 

In Global Safety Regions you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.  

 

As part of our local pharmacovigilance team of 3 persons, you will be performing in all kind of PV tasks and support in building our function even further. 

Your role

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. 

Responsibilities:

  • 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
Job ID Reference
1654
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. 

Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 Neu-Isenburg, Germany