Executive Search Firm Monroe Consulting Group is recruiting a Drug Safety Admin or Clinical Trial Safety Reporting Administrator on behalf of a multinational company who specializes in patient-centric drug development and commercialization services, aiming to provide reliable clinical research solutions to pharmaceutical and biotech firms. The Clinical Trial Safety Reporting Administrator is responsible for ensuring timely, accurate, and compliant submission of individual case safety reports (ICSRs) related to clinical trials. This role supports pharmacovigilance and clinical operations teams by managing safety documentation, coordinating with stakeholders, and maintaining regulatory compliance in accordance with ICH-GCP, FDA, EMA, and other global regulatory requirements. Working setup is fully remote.
Key Responsibilities:
Coordinate the collection, tracking, and submission of ICSRs and periodic reports to partners, regulatory authorities, ethics committees, and investigators.
Maintain safety reporting logs, ensuring data accuracy and completeness.
Monitor safety reporting timelines and escalate delays or issues to appropriate stakeholders.
Collaborate with clinical teams, CROs, and vendors to ensure proper documentation and reporting of safety events.
Assist in the distribution and submission of safety-related documents, including Development Safety Update Reports (DSURs), line listings, and other deliverables as required.
Support audits and inspections by providing documentation and responding to queries related to safety reporting.
Ensure compliance with applicable global regulatory requirements and internal SOPs.
Qualifications:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
1–3 years of experience in clinical trial safety reporting, pharmacovigilance, or clinical operations.
Knowledge of MedDRA and WHO Drug Dictionary coding.
Knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines.
Strong organizational skills and attention to detail.
Excellent communication and interpersonal skills.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Empresaria Group plc
Registered Address: Old Church House, Sandy Lane, Crawley, RH10 4HS