Sr. Safety Monitor I

Be Part of One Team, One Purpose. At cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units— Overview Sr. Safety Monitor I 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 Senior Safety Monitor I will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department under limited supervision. The Senior Safety Monitor I will be responsible for safety monitoring for interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team. In addition, the Senior Safety Monitor I will supervise the design 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/ Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Senior Safety Monitor I will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements. Responsibilities Performs safety monitoring activities in cooperation with project Medical Monitor/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 Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports. Coordinates the timely completion and submission of required reports to necessary health authorities and business partners. Maintains ongoing database of SAEs and reconciles SAEs in the database as needed. Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. 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, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non-interventional). Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary. Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report as well as 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 Management 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 related Case Report Forms (CRF) and SaMP. Ensures maintenance of documentation required by both corporate and project SOPs. Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOPs 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. 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. Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract. 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. Acts as a mentor/resource for junior colleagues. Drives other corporate activities including development and presentation of Emmes internal training courses, chairing of corporate safety meetings/activities, coordination of annual SOP reviews, coordination of cross-department working groups dedicated to improvement of work processes and development of innovative solutions and other relevant corporate activities. Qualifications Bachelor's Degree in pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice (e.g., pharmacy, inpatient or outpatient healthcare facility, clinical research center, etc.) 4-6 years related experience in research or with a pharmaceutical company (CRO, pharma company, etc.) with prior experience in safety monitoring/pharmacovigilance Required 1-3 years of experience in safety monitoring/pharmacovigilance with some mentoring of junior staff preferred Working knowledge of MedDRA and WHO Drug coding preferred. Demonstrated use of medical terminology and ability to extract information to create a case history. Consistency, quality, compliance and patient centricity respected as key values. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. Excellent oral and written communication skills. Ability to work as a team member and function on a cross-functional team. Capacity to provide leadership and creativity in the work environment. Detail oriented with good organizations skills. Ability to complete work autonomously. 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. Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status. #J-18808-Ljbffr Emmes Group