Patient Safety Associate I (Drug Safety Associate I)

• 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.