Patient Safety Associate I – Drug Safety Associate I

Work from home Full-time role Hiring

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:

More open positions