Medical Reviewer I
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- To review and approve post-marketing Individual Case Safety Reports (lCSRs) 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Individual Case Safety Reports (ICSRs)Serious Adverse Event (SAE) reportscodingmedicinal product safety assessmentliterature screeningsignal detectionPeriodic Safety Update Reports (PSUR)Development Safety Update Reports (DSUR)data analysisdocumentation
Soft skills
interpersonal skillsplanningorganizingprioritizingexecuting multiple taskscross-cultural communicationcross-functional teamwork
Certifications
medical qualification as a physician