Pharmacovigilance Officer
Czech Republic / Slovakia / Poland / Hungary (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.
Responsibilities
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
Experience
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)
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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