Emmes Group is a leading clinical research organization dedicated to transforming the future of medical discovery. With over 47 years of experience, Emmes has been a trusted partner for US government agencies, public-private partnerships, and commercial biopharma companies. The company specializes in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
At Emmes, we believe in building a better future through innovative clinical research. Our work directly impacts patient lives, and we foster a collaborative, performance-driven culture that values both people and progress.
Job Description: Safety Monitor II
Primary Purpose
The Safety Monitor II will support Pharmacovigilance (PV) activities under the guidance of the Pharmacovigilance and Medical Monitoring (PMM) team. This role involves monitoring, assessing, and reporting safety data from clinical trials (both interventional and non-interventional) while ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
Key Responsibilities
1. Safety Monitoring & Reporting
- Review and assess adverse events (AEs), serious adverse events (SAEs), and other safety-related data.
- Communicate with investigator sites, regulatory authorities, and healthcare professionals for additional safety information.
- Prepare SAE narratives for Medical Monitor review, DSMB reports, and regulatory submissions.
- Maintain an SAE database and ensure timely reporting to health authorities (FDA, EMA, etc.).
2. Clinical Trial Safety Oversight
- Participate in Data Safety Monitoring Board (DSMB) and Safety Review Committee (SRC) meetings.
- Contribute to safety sections of study protocols, Safety Management Plans (SaMP), and Case Report Forms (CRFs).
- Perform MedDRA and WHO Drug coding for adverse events.
3. Compliance & Quality Assurance
- Ensure adherence to GCP, GVP, and corporate SOPs.
- Support internal and external audits related to pharmacovigilance.
- Assist in developing and updating departmental SOPs and compliance documents.
4. Cross-functional Collaboration
- Work closely with Medical Monitors, Regulatory Teams, and Project Managers.
- Participate in corporate safety initiatives and process improvement activities.
Qualifications & Experience
- Bachelor’s degree in Pharmacology, Nursing, or a related scientific field.
- Minimum 2 years of experience in clinical research, pharmacovigilance, or pharmaceutical/CRO settings.
- Preferred: Experience in safety monitoring, pharmacovigilance, or clinical trial safety.
- Strong understanding of GxP (Good Practice) guidelines.
- Excellent clinical judgment, attention to detail, and organizational skills.
- Ability to work in a team and communicate complex safety issues clearly.
Why Join Emmes Group?
- Impactful Work: Contribute to life-changing clinical research.
- Collaborative Culture: Work with industry-leading experts.
- Career Growth: Opportunities for professional development and innovation.
