Medical Reviewer II Specialist
Há 5 dias
Company Overview
TN Portugal is a global leader in pharmacovigilance and drug safety services.
We are committed to improving the lives of patients by ensuring the safe and effective use of medications.
Safety Reporting Job 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.
- Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues.
- Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
- Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
- 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, 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.
Required Skills and Qualifications
- 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).
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