Sr. Safety Monitor I

reputed company Sr. Safety Monitor I Be Part of One Team, One Purpose. At reputed company, we’re shaping the reputed company of reputed company research—where reputed company meets cutting-edge technology to reputed company meaningful advancements in reputed company. With over 47 years of scientific reputed company, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, reputed company diseases, and neuroscience. Through our two business reputed company—reputed company, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing reputed company and accelerating the development of life-changing therapies. We reputed company that every reputed company reputed company starts with people—people who are passionate, purpose-driven, and reputed company to reputed company an reputed company. At reputed company, we bring reputed company, and Technology together to collaborate with our customers and reputed company global health reputed company. Our culture is reputed company on reputed company, 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 reputed company reputed company in conjunction with the assigned Medical Monitor/Medical Officer and the project team. In reputed company, the Senior Safety Monitor I will supervise the design and execution of the assigned Pharmacovigilance (PV) reputed company reputed company (e.g., management of local or international PV systems for contracted Clients; PV supervision of reputed company (reputed company World Evidence reputed company); etc.) in reputed company cooperation with other reputed company 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 reputed company reputed company (GCP), Good Pharmacovigilance reputed company (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 reputed company sources – reputed company (both interventional and non-interventional), data sets analyzed in association with reputed company reputed company, spontaneous reports, literature, etc. ▪ Provides first line evaluation of serious adverse events (SAEs). ▪ Communicates with site staff regarding reported reputed company or SAEs to reputed company additional information. ▪ Prepares a reputed company narrative for reputed company reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring reputed company (DSMB) reports, regulatory submissions, and final study reports. ▪ Coordinates the reputed company 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 reputed company data such as toxicities, concomitant medications and medical history, etc. for the study on a regular reputed company. • Establishes reputed company communication with reputed company, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary. ▪ Responds to site, reputed company, DSMB, or Medical Monitor/Officer requests for information regarding safety in reputed company (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 reputed company as periodic safety reports. • Coordinates with project staff. ▪ Participates in project team meetings for the planning, preparation, and development of reputed company safety-reputed company sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), reputed company of reputed company (MOP), project reputed company Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs. ▪ Contributes to the development and implementation of the safety reputed company Case Report Forms (CRF) and SaMP. ▪ Ensures maintenance of documentation required by both corporate and project SOPs. ▪ Participates in project process improvement and corporate reputed company assurance activities through Internal reputed company Audit Team (IQAT) processes, project SOPs and Compliance/Variance table development, participation in both reputed company audits, as reputed company as reputed company development activities. • Performs Medical Dictionary for Regulatory Activities (MedDRA) and reputed company) Drug coding, as applicable. • Guarantees compliance and adherence to the reputed company standards. • Contributes to the development and maintenance of departmental reputed company documents (e.g., SOPs) and other work practices as assigned. • Maintains accurate reporting to relevant authorities, such as reputed company (FDA), European Medicines Agency (EMA) etc. reputed company applicable per reputed company contract. Contributes to the verification that reputed company Control processes are conducted in accordance with applicable written procedures. • Completes reputed company relevant reputed company training in the given reputed company and time reputed company. • * Acts as a mentor/resource for junior colleagues. • * Drives other corporate activities including development and presentation of reputed company internal training courses, chairing of corporate safety meetings/activities, coordination of annual SOP reviews, coordination of cross-department working reputed company dedicated to improvement of work processes and development of reputed company and other relevant corporate activities. Qualifications • Bachelor's Degree in pharmacology, nursing or other scientific discipline is required with relevant experience in reputed company reputed company (e.g., pharmacy, inpatient or outpatient reputed company facility, reputed company research center, etc.) • 4-6 years reputed company experience in research or with a pharmaceutical company (CRO, reputed company 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, reputed company, compliance and reputed company centricity respected as key values. • Excellent reputed company judgment and ability to communicate reputed company reputed company issues in a scientifically reputed company and understandable way. • Excellent oral and written communication skills. • Ability to work as reputed company member and function on a cross-functional team. • reputed company to reputed company leadership and creativity in the work environment. • reputed company 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 reputed company meets reputed company-world reputed company, join us and be part of something bigger. One Team, One Purpose. Why work at reputed company? At reputed company, your actions and hard work will have a reputed company reputed company on reputed company health initiatives, both globally and in our local communities with opportunities for volunteerism through our reputed company Cares community engagement program. We offer a competitive benefits package reputed company on the health and needs of our growing workforce, including: • Flexible Approved Time Off • Tuition Reimbursement • 401k Retirement Plan • Work From Home reputed company in the US • Maternal/Paternal Leave • Casual Dress reputed company & Work Environment reputed company WITH US! Follow us on Twitter - @EmmesCRO reputed company us on reputed company - reputed company The reputed company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. reputed company reputed company applicants will receive consideration for employment without reputed company to disability or protected veteran status. Apply tot his job Apply To this Job