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Full-time
bachelor degree
Flexible working conditions, Extensive training, Competitive salary, Benefits package, Professional growth opportunities
Posted 11d ago
~40 hrs/week
Responsibilities
The Pharmacovigilance Coordinator will manage the receipt, documentation, and reporting of safety information for clinical trials, including data entry and quality control. They will also conduct literature searches in Japanese databases and maintain project-specific safety trackers.
Requirements
Candidates must hold a degree in Biology, Bioscience, or Pharmacy and possess full working proficiency in both English and Japanese. At least one year of experience in clinical research or a similar operational role is required.
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.
In this role, you will provide day-to-day support to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials with the corresponding services. You will process and report safety information (including electronic reporting) throughout the course of the clinical trials. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals and investigational devices, collect relevant and reliable medical scientific information.
The scope of responsibilities will include:
Serve as a contact point for Safety Desk and clinical project teams ensuring appropriate receipt, timely distribution, documentation, and filing of safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) reports.
Data entry of safety reports into the safety database
Non-medical review/triage of incoming safety reports
Quality control of data entered in the safety database
Safety queries distribution to sites/ investigators
Maintenance and timely update of the company’s project-specific SAEs distribution lists
Review and timely update of project-specific SAEs trackers maintained by PSI project teams
A literature search conduction in a dedicated Japanese scientific database and article triage.
Maintain pharmacovigilance documentation and associated records, ensuring all relevant information remains up to date and appropriately documented.
Qualifications
College or University Degree (Biology, Bioscience, or Pharmacy is preferred)
Full working proficiency in English and Japanese
At least 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory specialist, Data Management Specialist or the like will be a plus
Administrative work experience
Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus
Organizational and planning skills
Detail-oriented, able to multi-task and work in a fast-paced environment
Communication and collaboration skills
Proficiency in standard MS Office applications (Word, Excel and PowerPoint)
Additional Information
We offer:
Excellent and flexible working conditions
Extensive training and friendly, collegial team
Competitive salary and benefits package
Opportunities for personal and professional growth
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
How many Healthcare jobs are open in Prague, Czechia right now?
There are currently 201 open healthcare positions in Prague, Czechia listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Prague, Czechia?
Companies currently hiring include MSD, Johnson & Johnson Innovative Medicine, Boehringer Ingelheim, Novartis, Sandoz, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Prague, Czechia?
Yes — 98 of the 201 open healthcare positions offer remote or hybrid work (16 remote, 82 hybrid).
How do I apply for Healthcare jobs in Prague, Czechia?
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