Pharmacovigilance Officer

Mar 23, 2023
Mar 28, 2023
Full Time
Pharmacovigilance Officer

Slovenia (Remote )

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

For our growing team, we are looking for a Pharmacovigilance Officer to ensure that processing of Individual Case Safety Reports (ICSRs), literature screening and communication of safety information to relevant authorities are performed according to the pharmacovigilance (PV) Quality Documents, Clients' requirements and applicable legislation including Good Pharmacovigilance Practice.

  • To perform review, tracking and reporting of safety events to clients for assigned clinical studies and post-registration pharmacovigilance projects
  • To ensure follow-up communication with reporter or with investigator in case of clinical study
  • Review protocol, SMP (Safety Monitoring Plan) and other clinical study documents
  • To perform local literature monitoring, including review of the search results, identifying safety-related findings
  • To prepare monthly reports on local pharmacovigilance activities and monthly reconciliation
  • No -To ensure first-level medical information service for selected projects
  • To maintain awareness of current local pharmacovigilance legislation and local Regulatory Authority requirements
  • Possibility to act as a project leader, coordinating activities in several countries and being the first point of contact for client

  • Pharma / medical / life science university degree
  • Expected at minimum 1,5 years of experience in pharmacovigilance, preferably in clinical studies
  • Team cooperation, flexibility, good communication skills
  • Proactivity, willingness to learn
  • Active knowledge of English (both written and oral) and Slovenian

We offer
  • Interesting and independent work with career growth opportunities
  • Full time employment
  • Open and friendly company culture
  • Work from home office


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