Patient Safety Associate I – Drug Safety Associate I

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the receipt of safety reports from various sources and facilitate the prompt processing of pharmacovigilance data.

• Execute data entry, create cases, process cases, conduct quality checks, perform coding, follow up on activities, and prepare case narratives in safety databases.

• Assist in regulatory reporting by ensuring accurate processing, documentation, reconciliation, and tracking of safety cases and submissions.

• Perform literature searches, analyze and review scientific literature, identify potential safety information, and support the monitoring of literature.

• Submit Individual Case Safety Reports, periodic reports, and relevant documentation to regulatory bodies and stakeholders.

• Provide support for affiliate services, including the exchange of safety information, coordination of literature screening, translation assistance, follow-up activities, and data reconciliation.

• Keep documentation, records, and project files organized within the EDMS and eTMF environments.

• Manage regulatory databases, track submissions, support registrations, and aid in lifecycle management.

• Research, maintain, and update safety reporting requirements specific to countries and their associated records.

• Engage in project meetings, training programs, audits, inspections, and departmental initiatives.

• Raise issues to supervisors when necessary.

• Collaborate with experienced professionals across global teams to enhance patient safety and pharmacovigilance efforts.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or Biomedical Sciences (such as Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience.

• Basic understanding of drug safety regulations and pharmacovigilance processes.

• The ideal candidate should possess 3+ years of experience in Drug Safety.

• At least 2 years of experience in post-marketing activities.

• Experience across multiple therapeutic areas, including cardiology, neurology, oncology, and rare diseases.

• Exceptional attention to detail, strong organizational skills, and effective problem-solving abilities.

• Proficient communication skills and a readiness to work in a collaborative team setting.

• Competence in Microsoft Office applications.

• Capability to learn safety systems/databases.

• Preference for experience with Veeva Safety.

• Familiarity with pharmacovigilance systems, databases, and established workflows.

• Interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare sectors.

• Strong commitment to quality and compliance standards.

🏝️ 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.