Patient Safety Associate I (Drug Safety Associate I)

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1