Patient Safety Associate I (Drug Safety Associate I)

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Patient Safety Associate I (Drug Safety Associate I) based in United States.** This role supports essential pharmacovigilance and patient safety activities that help protect patients throughout the lifecycle of therapies. You will contribute to individual case safety report processing, regulatory submissions, literature monitoring, and safety data management. Working within established procedures and with guidance from experienced colleagues, you will help maintain high standards of accuracy, quality, and regulatory compliance. The position provides exposure to global safety operations and collaboration with cross-functional and international teams. You will work across multiple therapeutic areas while developing practical expertise in drug safety, regulatory requirements, and clinical research. Your attention to detail and analytical skills will directly contribute to the reliable handling of safety information. This fully remote U.S. opportunity is well suited to someone looking to grow a career in pharmacovigilance and patient safety. ### Accountabilities - Monitor incoming safety reports from multiple sources and support the timely processing of pharmacovigilance data. - Perform case creation, data entry, case processing, quality checks, medical coding, follow-up activities, and case narrative preparation in accordance with applicable procedures and client requirements. - Support regulatory compliance by accurately processing, documenting, reconciling, and tracking safety cases and submissions. - Prepare and support the submission of Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and other stakeholders. - Conduct literature searches and reviews to identify potential safety information and support ongoing literature monitoring activities. - Support affiliate services, including safety information exchange, literature screening coordination, translation activities, follow-ups, and data reconciliation. - Maintain accurate project documentation, records, and files across relevant systems, including electronic document management and clinical trial environments. - Support regulatory operations through database maintenance, submission tracking, registration activities, and lifecycle management. - Research and maintain country-specific safety reporting requirements as part of regulatory intelligence activities. - Participate in project meetings, training, audits, inspections, and departmental initiatives, escalating questions or issues to supervisors when appropriate. - Collaborate with global colleagues and cross-functional stakeholders to support consistent, high-quality patient safety services. ## Requirements - Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, or a related discipline, or equivalent education and experience. - Foundational knowledge of pharmacovigilance processes and drug safety regulations. - 3+ years of drug safety experience is preferred. - At least 2 years of post-marketing safety experience. - Experience working across multiple therapeutic areas, such as cardiology, neurology, oncology, or rare diseases. - Experience with pharmacovigilance systems, safety databases, established workflows, and Microsoft Office applications. - Veeva Safety experience is preferred. - Strong attention to detail, organization, analytical thinking, and problem-solving skills. - Ability to manage data and documentation accurately while meeting deadlines and regulatory requirements. - Clear written and verbal communication skills and the ability to collaborate effectively within a team environment. - Genuine interest in pharmacovigilance, patient safety, pharmaceutical development, healthcare, or clinical research. - Patient-focused mindset with a strong commitment to quality, compliance, confidentiality, and continuous learning. - Ability and willingness to learn new systems, processes, and regulatory requirements. ## Benefits - Fully remote work opportunity within the United States. - Health, vision, and dental insurance. - 401(k) retirement plan with company match. - Tuition reimbursement. - Paid vacation, holidays, and sick time. - Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA). - Work/life balance initiatives and flexible working arrangements. - Pet insurance. - Life insurance and additional benefits available to eligible employees. - Opportunities to develop expertise in pharmacovigilance, regulatory compliance, clinical research, and patient safety. - Exposure to global teams, multiple therapeutic areas, and a broad range of safety operations. - Compensation and benefits provided according to applicable employee benefit plans.