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 channels and assist in the prompt processing of pharmacovigilance data.

• Execute data entry, case creation, case processing, quality assessments, coding, follow-up tasks, and preparation of case narratives within safety databases.

• Facilitate regulatory reporting by processing, documenting, reconciling, and tracking safety cases and submissions.

• Conduct literature reviews, assess scientific publications, and pinpoint potential safety information.

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

• Assist affiliate services with safety information exchange, coordination of literature screening, translation support, follow-up tasks, and data reconciliation.

• Preserve documentation, records, and project files within EDMS and eTMF settings.

• Oversee regulatory databases, monitor submissions, support registrations, and aid in lifecycle management.

• Investigate and update country-specific safety reporting requirements and related records.

• Engage in project meetings, training sessions, audits, inspections, and departmental activities.

• Raise issues to supervisors when necessary.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, 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 have over 3 years of experience in Drug Safety.

• A minimum of 2 years of experience in post-marketing activities.

• Experience across several therapeutic areas (including cardiology, neurology, oncology, and rare diseases).

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

• Effective communication skills and a readiness to work collaboratively in a team environment.

• Proficient in MS Office and capable of learning safety systems/databases.

• Preference will be given to candidates with Veeva Safety experience.

• Experience with pharmacovigilance systems, databases, and established workflows is advantageous.

🏝️ 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

• Flexible work from home arrangement in the US