Patient Safety Associate I – Drug Safety Associate I

Job Description:

• Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data
• Perform data entry, case creation, case processing, quality checks, coding, follow-up activities, and case narrative preparation in safety databases
• Support regulatory reporting through accurate processing, documentation, reconciliation, and tracking of safety cases and submissions
• Conduct literature searches, screen and review scientific literature, identify potential safety information, and support literature monitoring
• Submit Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and stakeholders
• Support affiliate services, including safety information exchange, literature screening coordination, translation support, follow-up activities, and data reconciliation
• Maintain documentation, records, and project files in EDMS and eTMF environments
• Maintain regulatory databases, track submissions, support registrations, and assist with lifecycle management
• Research, maintain, and update country-specific safety reporting requirements and associated records
• Participate in project meetings, training programs, audits, inspections, and departmental activities
• Escalate issues to supervisors as appropriate
• Collaborate with experienced professionals across global teams to support patient safety and pharmacovigilance activities

Requirements:

• Bachelor’s degree in Life Sciences, Health Sciences, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience
• Foundational knowledge of drug safety regulations and pharmacovigilance processes
• Ideal candidate has 3+ years experience in Drug Safety
• 2+ years experience in post marketing
• Experience in multiple therapeutic areas, including cardiology, neurology, oncology, and rare disease
• Strong attention to detail, organizational skills, and problem-solving ability
• Effective communication and willingness to work in a collaborative team environment
• Proficiency with Microsoft Office
• Ability to learn safety systems/databases
• Preference for Veeva Safety experience
• Experience working with pharmacovigilance systems, databases, and established workflows
• Interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare environments
• Commitment to quality and compliance

Benefits:

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• Paid time off
• Life insurance
• Additional benefit offerings in accordance with the terms of applicable plans
• Work from home flexibility in the US