Safety Monitor Europe

Overview

Safety Monitor Europe - Czech Republic or Slovakia

Be Part of One Team, One Purpose.At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.The Safety Monitor Europe will implement Pharmacovigilance and Medical Monitoring (PMM) activities in collaboration with other members of the PMM. The Safety Monitor Europe will be responsible for safety monitoring for all interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor or Medical Officers and the project team. In addition, Safety Monitor Europe supervises the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers or Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. Safety Monitor Europe supports the adherence to Good Pharmacovigilance Practice (GVP) and to other relevant Pharmacovigilance requirements across Emmes EU organization.

Responsibilities

• Performs safety monitoring activities in cooperation with project Medical Monitor or Medical Officer and other relevant project team members.
• Reviews safety events.
• Oversees the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, pharmaceutical partner requests for information regarding safety in clinical trials (both interventional and non interventional).
• Participates in DSMB or other safety review committee (SRC) meetings as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report, and periodic safety reports.
• Coordinates with project staff.
• Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Monitoring Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SaMP).
• Ensures maintaining of documentation required by corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Within the assigned projects is accountable for the delivery of complex PV services related to contracted management of Client's PV system, i.e., ensures delivery of PV postmarketing services as defined in the relevant PvA (Pharmacovigilance Agreement) and/or relevant SOPs.
• Contributes to the negotiation of PvA with Client, ensuring the full PvA compliance with relevant internal and external regulations (e.g., local and European Union (EU) legislation, Client's SOPs, Emmes SOPs, etc.).
• Can be assigned as PV Project Responsible, where acts as a first point of contact for project level communication with the Client.
• Enforces compliance to the signed PvA, while full adherence to all relevant PV requirements (such as EU and local legislation, Client's SOPs, Emmes SOPs, etc.).
• Ensures that delivery of all PV services, relevant documents and relevant correspondence related to assigned project are properly documented and tracked in compliance with PvA and relevant SOPs and requirements.
• Ensures that all documentation relevant for the assigned project is always audit/inspection ready.
• Enforces that the delivery of services to the specific Client is regularly monitored and invoiced in a transparent way in full compliance with the relevant contract.
• If appointed National Person Responsible for Pharmacovigilance (NPRP) or Local Person for Pharmacovigilance (LPPV), performs relevant activities in compliance with Good Pharmacovigilance Practice, local and European legislation, Client standard documents, job descriptions and applicable contract; primary point of contact for the relevant national regulatory authority 24/7; monitors and keeps abreast of changes to local PV/Regulatory legislation and published literature regarding safety concerns of relevant medicinal products.
• Represents Emmes in case of audit or inspection directly or indirectly related to the specific PV project.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned, the consistency with GVP, relevant local and international legislation and with requirements of relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA), etc.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Practices monthly quality checks.
• Participates in other corporate activities, e.g., corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the ways of working and development of innovative solutions and other relevant corporate initiatives.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Pharmacology, medicine or nature science preferred. Lower level of education accepted, if directly related to clinical medicine or pharmaceutical sciences or fully certified nurse. Required
• 4-6 years in pharmacovigilance. Required
• 1-3 years Experience from clinical practice (e.g., work in pharmacy or in research) and any experience in pharmacovigilance Preferred
• The readiness to work in a regulated environment and understanding of the Good x Practice, GxP, principles. High
• Ability to learn and understand quickly. High
• Consistency, quality, compliance and patient centricity respected as key values. High
• Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way. High
• Ability to work as a team member and function on a cross functional team. High
• Ability to direct activities and encourage positive team based culture. High
• Capacity to provide leadership and creativity in the work environment. High
• Excellent verbal and written communication skills. High
• Fluent in English. High

 

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.CONNECT WITH US!Find us on LinkedIn:/the-emmes-group/Visit our website:https://www.theemmesgroup.com/