Post Marketing Surveillance Director

Director of Global Post Marketing Surveillance

Location: Vienna, Austria

– Can also be based in Sweden, the United Kingdom, or France

Engagement: Full Time Position

Flexibility: Hybrid role, if in Vienna 5 days a month in offices. Can vary to suit your location

The Company:

A medium sized pharmaceutical company with 3 commercialised products and much more coming in the pipeline, the company has focused their efforts on providing products first-of-it’s-kind vaccines to address previously unmet medical needs. Every member of the team is driven by the knowledge their efforts are providing highly needed solutions for the patients. As an organisation they value internal collaboration and enabling their employees to have an impact on the company.

The Role:

In this newly created position, you will be responsible for independently managing multiple clinical studies. You’ll be supporting Ministry of Health, regulatory agencies, sites and vendors related topics.
As the lead of a cross-functional team, you will be driving the global execution of post marketing studies from the design through to the study close out.

This is a high value position within the organisation, and they are expecting to take on new headcount reporting into this position early next year.

Responsibilities:

• Lead the protocol design, study execution and data analysis/ reporting
• Closely collaborates with Regulatory Affairs and Medical Affairs on preparing data/ reports for submission
• Lead cross-functional teams (including Clinical Strategy, Pharmacovigilance, Medical Affairs, Regulatory Affairs, Market Access) for the development of strategies to meet post-marketing requirements
• Contribute to the development of study specific documentation e.g. case report forms (CRF), data management plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Lead publication/ dissemination of PMS study results and lead risk assessment and identify risk mitigation strategies at the study and product level

Ideal Experience you’ll bring to the role:

• Strong Scientific understanding (MSc or PhD)
• Highly knowledgeable about Phase IV
• Coming with an understanding of Efficacy, and Real-World Evidence
• Experience within Vaccine, Outbreak disease, Epidemiology, or Infectious Diseases is advantageous.
  • Fluent in English, working proficiency in German or Spanish is a benefit