Job Description

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. Participating 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.