Opera CRO
Opera CRO is a clinical research organization based in Romania, previously known as Opera CRO. The company has rebranded to Tigermed and is focused on providing comprehensive clinical research services to support the pharmaceutical and biotechnology industries.
Clinical Research • Clinical Trials • medical devices • early phsase research • proof of concept
Medical Reviewer I
February 11
Opera CRO
Opera CRO is a clinical research organization based in Romania, previously known as Opera CRO. The company has rebranded to Tigermed and is focused on providing comprehensive clinical research services to support the pharmaceutical and biotechnology industries.
Clinical Research • Clinical Trials • medical devices • early phsase research • proof of concept
📋 Description
• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. • Review includes coding, assessment of seriousness, listedness / expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. • Including completion of all required supporting documentation such as trackers. • To review literature screening search strategy • To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings. • Reviewing database outputs • To review and provide input in Periodic Safety Update Reports • To review and provide input in Development Safety Update Reports • Participating in signal detection activities including meetings and writing signal detection reports • Proposing a course of action whenever a possible signal is identified
🎯 Requirements
• Medically qualified as a physician with demonstrated experience in Pharmacovigilance • Any experience in aggregate reports and signal detection is desirable • Excellent interpersonal skills • Ability to plan, organise, prioritise and execute multiple tasks • Ability to work effectively cross culturally and cross functionally and value the importance of teamwork • Communication skills • Presentation skills
🏖️ Benefits
• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language
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