Medical Monitor

pJoin HEMEX, A European Contract Research Organization based in Liestal, Switzerland, dedicated to advancing global healthcare through innovative biotechnology research. As a Medical Monitor specializing in Pharmacovigilance and Medical Device Safety, you'll play a crucial role in ensuring the safety and efficacy of groundbreaking pharmaceutical, biotech, and medtech solutions. With our comprehensive clinical development services, including regulatory support and quality assurance, you'll have the opportunity to work on multinational clinical trials and contribute to the translation of novel concepts into market-ready solutions. /p h3Tasks /h3 ul liThe Medical Monitor is responsible for providing medical oversight across clinical trials, with a particular focus on patient safety, pharmacovigilance, medical device safety, and the medical review of clinical trial data. /li liThe role works closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, investigators, sponsors, and other cross-functional teams to ensure that safety information is appropriately identified, medically assessed, documented, escalated, and reported. /li liFunctional Responsibilities /li /ul pb1. Medical Safety Monitoring /b /p ul liConduct ongoing medical review of clinical trial data to identify and evaluate potential safety signals. /li liReview adverse events (AEs), serious adverse events (SAEs), medical histories, concomitant medications, laboratory results, vital signs, and other relevant safety information. /li liAssess the medical significance, seriousness, severity, expectedness, and clinical relevance of adverse events. /li liProvide medical guidance regarding appropriate follow-up and management of safety events. /li liIdentify emerging safety trends and escalate potential safety signals according to applicable procedures. /li liProvide medical input into safety surveillance activities throughout the clinical trial. /li liAnswer medical queries from sites and the project team, including eligibility questions, and review protocol deviations with potential medical or safety impact. /li liReview the coding of adverse events, medical history, and concomitant medications (MedDRA, WHODrug) for medical accuracy. /li liSupport emergency unblinding decisions for medical reasons in line with the protocol and study procedures, where applicable. /li /ul pb2. Pharmacovigilance Support /b /p ul liProvide medical oversight and guidance for pharmacovigilance activities. /li liSupport the medical assessment of Individual Case Safety Reports (ICSRs). /li liSupport the assessment and expedited reporting of suspected unexpected serious adverse reactions (SUSARs) and the submission of IC RS to EudraVigilance in line with Regulation (EU) No 536/2014. /li liCreate and maintain medicinal product records in XEVMPD (and, once introduced, its successor, the EMA Product Management Service, PMS). /li liReview safety cases and provide medical input on case narratives, seriousness, causality, and expectedness where applicable. /li liEnsure that safety information is appropriately reconciled between Clinical Data Management and Pharmacovigilance. /li liSupport preparation and review of safety reports and regulatory safety documentation. /li /ul pb3. Medical Device Safety /b /p ul liProvide medical oversight for clinical investigations involving medical devices. /li liReview and medically assess device-related adverse events, serious adverse events, adverse device effects (ADEs), serious adverse device effects (SADEs), unanticipated serious adverse device effects (USADEs), device deficiencies, and other safety events. /li liSupport the identification and evaluation of potential device-related safety signals. /li liProvide medical input into device safety assessments, benefit-risk considerations (including links to the risk management file under ISO 14971), and safety escalation processes. /li liSupport safety reporting for clinical investigations of medical devices in line with Regulation (EU) 2017/745 (MDR) Article 80 and MDCG /1, including causality assessment. /li liCollaborate with Clinical Operations, investigators, Data Management, and Regulatory Affairs regarding device safety issues. /li liEnsure device safety activities are performed according to the protocol, applicable procedures, and relevant regulatory requirements (ISO 14155 and Regulation (EU) 2017/745). /li /ul pb4. Protocol and Study Design Support /b /p ul liReview and provide medical input into clinical study protocols. /li liContribute to the selection of clinically appropriate endpoints, inclusion/exclusion criteria, and safety monitoring procedures. /li liDevelop, review, and maintain the Medical Monitoring Plan, study-specific safety management plans, and related documentation. /li liProvide medical input into informed consent forms, Investigator's Brochures, safety plans, and other clinical documents. /li /ul pb5. Investigator and Team Support /b /p ul