Job Description

Clinical Safety Specialist

Responsibilities:

• Monitor patient safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments.
• Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities.
• Provide medical expertise to clinical study teams, investigators, and safety personnel for safety-related queries and escalations.
• Lead or participate in the assessment of causality, expectedness, and severity of adverse events.
• Oversee the development of risk management plans and ensure compliance with REMS (Risk Evaluation and Mitigation Strategies).
• Support the preparation of safety documents, including DSURs, PSURs, and safety narratives.
• Participate in regulatory inspections and audits, ensuring safety systems and databases (e.g., Argus, ArisGlobal) are compliant and up to date.
• Analyze clinical trial safety data; present at Data Safety Monitoring Board (DSMB) meetings.
• Contribute to signal detection and risk-benefit analysis by reviewing empirical data and literature.
• Ensure compliance with standard operating procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies.
• Review experimental protocols and informed consent documents; prepares, reviews, and edits presentations regarding safety review committee meetings.
• Assist in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary.
• Maintain/update agent-specific clinical and preclinical toxicity study summary tables for investigational agents.
• Develop and implement Safety Management Plan and Medical Monitoring Plan.

Requirements:

• Knowledge of regulatory guidelines (FDA, EMA, ICH, GCP) and safety reporting regulations (e.g., E2B, MedWatch, CIOMS).
• Proficiency in MedDRA coding and adverse event classification (e.g., CTCAE, DAIDS).
• Experience in handling serious adverse events (SAEs), signal detection, and risk management.
• Medical degree (MD, DO, or equivalent) is required.
• Board certification in a relevant field (e.g., internal medicine, pediatrics, or subspecialties like immunology or oncology) is often preferred.
• Experience in pharmacovigilance and clinical trials, with 5-10 years in safety monitoring or clinical research roles.
• 3-5 or more years of relevant work experience in drug safety, human subject protection, in the biotech and/or pharmaceutical industry.
• 2 or more years of clinical research and/or experience as principal investigator, medical monitor.
• 2 or more years of clinical practice; experience in oncology, internal medicine, infectious diseases a plus.
• Strong communication and problem-solving skills for interacting with study teams, investigators, and regulatory authorities.
• Excellent written and verbal communication skills, with experience in medical writing and safety documentation.
• Strong analytical and problem-solving skills, with the ability to interpret and summarize complex safety and medical research data.
• Experience in training and mentoring junior staff is a plus.

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