Full-Time Medical Reviewer II

Review and Approve Post-Marketing ICSRs and SAEs: Review and approve individual case safety reports (ICSRs) and serious adverse event (SAEs) reports from clinical trials, assessing causality and medical issues. This includes coding, seriousness assessment, company causality, comment, listedness/expectedness, and follow-up questions.

Qualified Person Support: Act as Qualified Person for Pharmacovigilance or assist the Qualified Person in medical evaluation of safety issues.

Input to Safety Reports: Review and provide input to Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening search strategies.

Literature Review: Review articles to find ICSRs/SAEs or other safety findings related to medicinal products.

Risk Management: Participate in preparing and providing input for Risk Management Plans, and responses to regulatory requests.

Signal Detection: Participate in signal detection activities, including meetings, report writing if needed, and consulting on benefit/risk assessment.

Signal Evaluation: Evaluate possible safety signals, categorize them, and propose courses of action.

Benefit-Risk Reports: Support preparation and review of benefit-risk reports.

Requirements:

• Medical Qualification: PV Physician should be medically qualified (physician).
• Pharmacovigilance Experience: Previous experience in pharmacovigilance.
• Aggregate Report Review: Ability to review various aggregate reports (e.g., PBRERs, DSURs).
• Signal Detection Expertise: Expertise in signal detection activities is essential.
• Interpersonal & Communication Skills: Excellent interpersonal and communication skills, presentation skills.
• English Proficiency: Advanced English (spoken and written).
• Other skills: Planning, organizing, prioritizing, executing tasks, working cross-culturally and cross-functionally, strong teamwork, advanced MS Office literacy.

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