Medical Reviewer I
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇵🇹 Portugal
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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
codingmedical/causality assessmentliterature screeningsignal detectionPeriodic Safety Update ReportsDevelopment Safety Update ReportsIndividual Case Safety ReportsSerious Adverse Event reportsdocumentation completiondata analysis
Soft skills
interpersonal skillsplanningorganizingprioritizingexecutioncross-cultural teamworkcross-functional collaborationcommunication skillspresentation skills
Certifications
medical qualification as a physician