Medical Monitor​/Pharmacovigilance & Medical Device Safety min

Join 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.

• The 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.
• The 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.
• Functional Responsibilities

1. Medical Safety Monitoring

• Conduct ongoing medical review of clinical trial data to identify and evaluate potential safety signals.
• Review adverse events (AEs), serious adverse events (SAEs), medical histories, concomitant medications, laboratory results, vital signs, and other relevant safety information.
• Assess the medical significance, seriousness, severity, expectedness, and clinical relevance of adverse events.
• Provide medical guidance regarding appropriate follow-up and management of safety events.
• Identify emerging safety trends and escalate potential safety signals according to applicable procedures.
• Provide medical input into safety surveillance activities throughout the clinical trial.
• Answer medical queries from sites and the project team, including eligibility questions, and review protocol deviations with potential medical or safety impact.
• Review the coding of adverse events, medical history, and concomitant medications (MedDRA, WHODrug) for medical accuracy.
• Support emergency unblinding decisions for medical reasons in line with the protocol and study procedures, where applicable.

2. Pharmacovigilance Support

• Provide medical oversight and guidance for pharmacovigilance activities.
• Support the medical assessment of Individual Case Safety Reports (ICSRs).
• Support the assessment and expedited reporting of suspected unexpected serious adverse reactions (SUSARs) and the submission of IC RS to Eudra Vigilance in line with Regulation (EU) No 536/2014.
• Create and maintain medicinal product records in XEVMPD (and, once introduced, its successor, the EMA Product Management Service, PMS).
• Review safety cases and provide medical input on case narratives, seriousness, causality, and expectedness where applicable.
• Ensure that safety information is appropriately reconciled between Clinical Data Management and Pharmacovigilance.
• Support preparation and review of safety reports and regulatory safety documentation.

3. Medical Device Safety

• Provide medical oversight for clinical investigations involving medical devices.
• Review 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.
• Support the identification and evaluation of potential device-related safety signals.
• Provide medical input into device safety assessments, benefit-risk considerations (including links to the risk management file under ISO 14971), and safety escalation processes.
• Support safety reporting for clinical investigations of medical devices in line with Regulation (EU) 2017/745 (MDR) Article 80 and MDCG 2020-10/1, including causality assessment.
• Collaborate with Clinical Operations, investigators, Data Management, and Regulatory Affairs regarding device safety issues.
• Ensure device safety activities are performed according to the protocol, applicable procedures, and relevant regulatory requirements (ISO 14155 and Regulation (EU) 2017/745).

4. Protocol and Study Design Support

• Review and provide medical input into clinical study protocols.
• Contribute to the selection of clinically appropriate endpoints, inclusion/exclusion criteria, and safety monitoring procedures.
• Develop, review, and maintain the Medical Monitoring Plan, study-specific…