R0000038960 Patient Safety Associate I (Drug Safety Associate I) Full Time

At Parexel, we’re dedicated to improving patient health worldwide. As a Patient Safety Associate I, you’ll play a vital role in supporting drug safety, clinical trials, and post‑marketing surveillance activities in post-market surveillance, with some exposure to clinical trials, ensuring full compliance with regulatory requirements and Standard Operating Procedures (SOPs).

As a Patient Safety Associate I, you’ll be responsible for several key activities including processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency, conducting comprehensive literature searches and reviews to identify safety signals, and supporting signal detection and management activities. You’ll track and monitor regulatory information updates, assist in preparing and executing regulatory submissions, and contribute to the development of aggregate reports and study-specific safety documents. Where applicable, you’ll also manage Medical and Product Dictionary activities. Your role will be crucial in maintaining compliance through quality reviews of safety deliverables, generating metrics and performance indicators for safety operations, investigating and documenting late deliverable incidents, and ensuring adherence to international and local regulatory reporting requirements.

We’re looking for candidates with strong attention to detail and commitment to quality, an understanding of drug safety regulations and pharmacovigilance principles, excellent organizational and time management skills, the ability to work collaboratively in a team environment, and strong written and verbal communication skills. Join a global leader in Clinical Research Organization services, where you’ll contribute to improving patient safety worldwide while developing your career in pharmacovigilance.

What You’ll Do

General Safety Operations

• Follow project-specific procedures and regulatory standards.
• Support basic compliance activities, documentation, metrics, and audit preparation.
• Work collaboratively with team members and complete required training programs.

ICSR (Individual Case Safety Report) Processing

• Review, triage, and process safety reports from various sources.
• Perform data entry in safety databases with accuracy and medical consistency.
• Assist with follow-ups, case narrative preparation, MedDRA coding, and quality checks.
• Support compliance investigations and metrics reporting.
• Prepares medically cohesive case narratives based upon the reported information.

Safety Submissions

• Submit ICSRs and periodic safety reports to Health Authorities and stakeholders.
• Maintain regulatory submission schedules and reporting rules.
• Assist in audit preparation and regulatory intelligence updates.
• Support global reporting configuration and compliance activities.

Literature Search & Review

• Develop and maintain literature search strategies.
• Screen published articles for potential safety signals or adverse events.
• Conduct quality checks and manage journal reviews.
• Collaborate with internal teams for full-text retrieval and assessment.

Affiliate Services

• Support communication between global operations and local safety affiliates.
• Assist with safety information exchange, translations, and compliance tasks.
• Conduct literature monitoring and data reconciliation activities.

Regulatory Support

• Maintain regulatory systems and product registrations.
• Assist with submissions (eCTD), renewals, variations, and lifecycle management.
• Verify data accuracy and generate quality and compliance reports.

Regulatory Intelligence

• Research and maintain global safety reporting requirements.
• Update regulatory intelligence databases and trackers.
• Support day-to-day operations within the Global Pharmacovigilance Intelligence Office.

Your Knowledge & Experience

• Foundational knowledge of drug safety regulations and pharmacovigilance processes. Ideal candidate has 3+ years experience in Drug Safety.
• 2+ years experience in a post marketing.
• Experience in multiple therapeutic areas (cardiology, neurology, oncology, 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 MS Office and ability to learn safety systems/databases. Preference for those with Veeva Safety experience.

Education

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

This role offers the flexibility to work from home in the US.