Senior PV Specialist / Local Drug Safety Officer CZ

ID 15185
Join a large international and dynamically growing pharmaceutical company with generic, specialty and biological portfolio by providing local affiliate support for pharmacovigilance.

 

The primary role of Local Drug Safety Officer is to support local affiliate activities within the scope of EU PV guidelines and company SOPs and directives.

Your main responsibilities:

  • Full-scope company PV agenda in line with EU and interna directives
  • Audits and CAPA management from state authorities and internal audits
  • Drug safety evaluation during post-authorization period
  • Literature monitoring
  • AE reporting and follow-up
  • Translation of relevant cases and medical data
  • Participation in case management process
  • External reconciliation with 3rd parties, patient registries
  • Internal reconciliation with Quality and Medical team
  • Participation in routine PV activities such as conducting ad-hoc and annual internal company trainings
  • Effective communication with relevant stakeholders
  • Risk Management Plans – implementation, monitoring, communication with marketing team and authorities
  • Creation and management of local SOPs
  • Support to regulatory department in preparation and management of safety variations if needed

Our requirements:

  • University degree - preferably MD, PharmDr. (or other life science)
  • Previous experience in pharmacovigilance for at least 2 years is a must
  • Proven excellent communication and organization skills
  • Interest in the area of pharmacovigilance
  • Willingness and desire to learn new things
  • Highly advanced level of Czech and English
  • Strong PC skills
  • Detail oriented, hardworking personality
  • Team player

We offer

  • Challenging career opportunity to work for a successful international company with wide range of products
  • Opportunity to broaden your knowledge and expertise in PV and other fields
  • Possibilities for own personal growth and further language development
  • Competitive remuneration and wide portfolio of employee benefits
  • Above-standard social, healthcare and educational program
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