ERGOMED
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
Oncology • Neurology • Respiratory diseases • Orphan drugs • Metabolic diseases
Medical Reviewer II
April 24
ERGOMED
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
Oncology • Neurology • Respiratory diseases • Orphan drugs • Metabolic diseases
📋 Description
• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. • The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. • To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues. • To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, 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. • To cooperate in the preparation of and provide input in Risk Management Plans. • Supporting the preparation of responses to regulatory authority requests. • Signalling Reviewing line listings. • Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation. • Evaluating and categorizing possible signals and proposing a course of action. • Supporting preparation and review of benefit-risk reports.
🎯 Requirements
• The PV Physician should be medically qualified as a physician • Previous experience in pharmacovigilance • Ability to review different aggregate report types including PBRERs and DSURs • Expertise in signal detection activities is essential • 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 • English - advanced (spoken, written) • Advanced literacy (MS Office)
🏖️ 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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