Clinical Safety Monitor

Job Summary

We are seeking an experienced and detail-oriented Clinical Safety Monitor to support the oversight of patient safety throughout clinical trials. The Clinical Safety Monitor will review and monitor safety data, identify potential safety signals, ensure appropriate reporting of adverse events, and work closely with Clinical Operations, Pharmacovigilance, Medical Affairs, Data Management, and Regulatory teams.

The ideal candidate will have experience in clinical safety surveillance, adverse event review, safety data monitoring, clinical trials, and Google Cloud Platform/regulatory requirements within a pharmaceutical, biotechnology, CRO, or medical device environment.

Key Responsibilities

• Monitor and review clinical trial safety data to identify potential safety concerns and emerging safety signals.
• Review Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and other safety information.
• Evaluate safety data for accuracy, completeness, consistency, and clinical relevance.
• Support ongoing safety surveillance and risk assessment throughout the clinical trial lifecycle.
• Collaborate with Clinical Operations, Pharmacovigilance, Medical Monitors, Data Management, Biostatistics, and Regulatory teams.
• Review and follow up on safety-related queries and discrepancies with clinical sites and study teams.
• Monitor compliance with clinical trial protocols, safety reporting requirements, SOPs, and applicable regulations.
• Support review and reconciliation of safety data between clinical databases and safety/pharmacovigilance systems.
• Assist with identification, documentation, and escalation of potential safety signals and emerging risks.
• Support preparation and review of safety-related reports, listings, and study documentation.
• Participate in safety review meetings and communicate relevant safety findings to study stakeholders.
• Assist with the review of SAE narratives, safety listings, and patient-level safety data as applicable.
• Support medical review activities and escalation of significant safety concerns to the appropriate medical/safety personnel.
• Contribute to safety risk management activities, including review of trends and potential signals.
• Ensure appropriate documentation and tracking of safety issues and follow-up actions.
• Support inspection readiness and provide safety documentation during audits or regulatory inspections.
• Ensure all activities comply with ICH-Google Cloud Platform, FDA/EMA regulations, company SOPs, and applicable pharmacovigilance requirements.

Required Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related healthcare/scientific field.
• 2–5+ years of experience in clinical research, clinical safety, pharmacovigilance, or a related function.
• Experience reviewing and monitoring clinical trial safety data.
• Strong understanding of Adverse Events (AE), Serious Adverse Events (SAE), AESI, SUSAR, and safety reporting processes.
• Knowledge of ICH-Google Cloud Platform and applicable clinical safety regulations.
• Experience working with clinical trial databases and/or safety systems.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Excellent written and verbal communication skills.
• Ability to work effectively with cross-functional and global teams.
• Strong organizational skills and ability to manage multiple studies, priorities, and deadlines.

Preferred Qualifications

• Experience in Pharmaceutical, Biotechnology, CRO, or Medical Device organizations.
• Experience with Pharmacovigilance (PV) and clinical safety surveillance.
• Familiarity with safety databases such as Argus Safety, ARISg, Veeva Safety, or similar systems.
• Experience with clinical systems such as EDC, CTMS, and eTMF.
• Knowledge of MedDRA coding and WHO Drug coding.
• Experience with signal detection and safety trend analysis.
• Familiarity with DSUR, PBRER, IB, ICF, and other clinical safety documents.
• Experience supporting regulatory inspections and audits.
• Experience in specific therapeutic areas such as oncology, CNS, cardiovascular, immunology, or rare diseases is a plus.