Safety Medical Reviewer Consultant– Immunology

Job Description: Safety Medical Reviewer (Immunology)

Position Title: Safety Medical Reviewer – Immunology

Location: [Remote]Employment Type: [Contract]

Job Summary:

We are seeking a highly skilled Safety Medical Reviewer with expertise in immunology to join our pharmacovigilance team. The incumbent will be responsible for medical review and assessment of safety data to ensure patient safety and regulatory compliance. The ideal candidate will have strong analytical skills, a deep understanding of immunological conditions, and experience in drug safety or pharmacovigilance.

Key Responsibilities:

• Medical Review and Analysis:
• Conduct detailed medical review of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements.
• Assess adverse event reports related to immunology products and determine the causality and clinical significance.
• Provide medical input for case narratives and data coding using MedDRA and WHO-DD.
• Safety Signal Detection and Risk Assessment:
• Contribute to safety signal detection activities and risk assessments specific to immunology therapeutic areas.
• Collaborate with cross-functional teams to evaluate safety signals and support safety management strategies.
• Regulatory Reporting and Compliance:
• Ensure timely and accurate submission of safety reports to global health authorities.
• Maintain compliance with regulatory guidelines, including FDA, EMA, and ICH regulations.
• Collaboration and Communication:
• Collaborate with clinical development, regulatory affairs, and other departments to provide medical expertise on safety issues.
• Participate in safety review meetings and contribute to risk management plans.
• Continuous Improvement and Training:
• Contribute to the development of standard operating procedures (SOPs) and safety review processes.
• Provide training and mentorship to junior safety reviewers and pharmacovigilance staff.

Qualifications and Experience:

• Education:
• Medical degree (MD or equivalent) with specialization in Immunology or related field preferred.
• Advanced degree (e.g., PhD, PharmD) with significant immunology experience may be considered.
• Experience:
• Minimum [3] years of experience in pharmacovigilance, drug safety, or medical review, with a focus on immunology therapeutic areas.
• Experience in clinical practice or clinical research in immunology is an advantage.
• Skills and Competencies:
• In-depth knowledge of immunological diseases and biologic therapies.
• Strong analytical and clinical judgment skills.
• Proficiency in safety databases (e.g., Argus, ArisG) and coding dictionaries (MedDRA, WHO-DD).
• Excellent communication and presentation skills.
• Detail-oriented with the ability to manage multiple tasks and prioritize effectively.

Preferred Qualifications:

• Experience with safety signal detection and risk management in immunology.
• Familiarity with global pharmacovigilance regulations (e.g., FDA, EMA, ICH).
• Previous experience in a pharmaceutical or biotechnology company is a plus.

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