Medical Monitor /Pharmacovigilance & Medical Device Safety min 50%

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.

Tasks

• 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 ICSRs to EudraVigilance 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 safety management plans, and related documentation.
• Provide medical input into informed consent forms, Investigator's Brochures, safety plans, and other clinical documents.

5. Investigator and Team Support

• Provide medical training and support to investigators and clinical trial teams, including protocol-specific medical training at kick-off and investigator meetings.
• Support investigators in the appropriate identification, documentation, and reporting of safety events.
• Provide medical expertise to Clinical Operations, Customer Operations, Data Management, Biostatistics, and Project Management.
• Advise and participate in Data Safety Monitoring Boards (DSMBs), Safety Review Committees, and sponsor safety meetings, as applicable.
• Support the development of medical and safety expertise within the HEMEX Research India team.

6. Safety Reporting and Documentation

• Prepare and review medical safety summaries and reports.
• Provide medical input into Clinical Study Reports (CSRs), Clinical Investigation Reports (CIRs), publications, regulatory submissions, Development Safety Update Reports (DSURs), Annual Safety Reports (ASRs), and other safety-related documentation as applicable.
• Ensure medical documentation is complete, accurate, traceable, and inspection-ready.
• Keep documentation and handover notes up to date so that the named backup can cover planned and unplanned absences.

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Requirements

• Medical degree (MD, MBBS, or equivalent).
• At least 2 years of relevant experience in clinical research, medical monitoring, pharmacovigilance, or medical device safety.
• EMA ICSR and XEVMPD certificates (required to act as Responsible Person for Pharmacovigilance, RPPV).
• Experience with clinical trial safety assessment and adverse event management.
• Knowledge of ICH-GCP, ISO 14155, and relevant clinical research regulations (e.g., Regulation (EU) No 536/2014 and Regulation (EU) 2017/745).
• Experience with pharmaceutical and/or medical device clinical trials.
• Strong understanding of clinical safety concepts and medical terminology.
• Working knowledge of MedDRA coding.
• Experience working in a CRO, pharmaceutical, biotechnology, or medical device environment is preferred.
• Strong medical judgment and attention to patient safety.
• Excellent analytical and communication skills.
• Fluent English (written and spoken).
• High level of attention to detail.
• Ability to work independently while operating effectively within cross-functional teams.
• Strong documentation and quality mindset.
• Ability to work according to SOPs and standardized processes.
• Ability to identify issues early and escalate them appropriately.
• Availability to assess urgent safety events within agreed timelines, including out-of-hours coverage as agreed.
• Commitment to continuous learning and quality improvement.

Benefits

Flexible working arrangements and hybrid work options
Modern, international and entrepreneurial working environment

Opportunities for professional growth and continuous learning

High level of autonomy and responsibility

Collaborative team culture with direct communication and short decision-making paths

Central location with good public transport connections

Opportunity to work with innovative companies and projects in a dynamic industry

Join HEMEX AG as a Medical Monitor to impact global healthcare. Contribute to advancing biotech innovations in a dynamic, multinational team. Explore your potential with us today.

HEMEX is a European Contract Research Organization (CRO) supporting pharmaceutical, biotech, and medtech SMEs with end-to-end clinical development solutions. Headquartered in the Basel region, with offices in Germany, the Benelux region, and across three continents, the organization specializes in multinational clinical trials. Services include clinical operations, regulatory support, quality assurance, BA/BE, PK, and Phase I studies, rapid patient recruitment, and imaging core lab services. In addition, the HEMEX has access to CRDMO services, enabling the translation of novel concepts into commercialization through research-driven API development and end-to-end solutions that advance global healthcare and pharmaceutical innovation.