Job Description

• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company´s goals and objectives
• Works under supervision of more experienced colleague
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• Database Outputs and Reports (including data for monthly reporting to clients)

Qualifications

We expect:

• Interested in pursuing a career in pharmacovigilance
• Knowledge of additional foreign language is an advantage
• Good IT skills (MS Office)
• People who are excited to learn and contribute to patient safety
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication skills

Additional Information

We offer:

• Full-time position
• Pharmacovigilance and other professional trainings
• Various directions of career development
• Competitive salary and benefits

If you would like to be considered for this opportunity, please send your application electronically enclosing your English CV. Due to high a volume of applications only short-listed candidates will be contacted.