Pharmacovigilance Associate I — Patient Safety (Remote)

Parexel; Dover; Remote; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Job summary

Parexel is seeking a Patient Safety Associate I to join its pharmacovigilance team. The role focuses on safety data processing, regulatory submissions, literature screening, and compliance in a global clinical development setting.

You will gain exposure to a broad range of PV processes, collaborating with global teams to support drug safety, regulatory timelines, and high-quality patient safety services while contributing to innovative therapies.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences or equivalent experience.
• Foundational knowledge of drug safety regulations and pharmacovigilance processes; 3+ years in Drug Safety preferred.
• 2+ years experience in 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; Veeva Safety experience preferred.

Responsibilities

• Monitor incoming safety reports and support timely processing of pharmacovigilance data.
• Data entry, case creation, processing, quality checks, coding, and case narrative preparation in safety databases.
• Support regulatory reporting requirements through accurate processing, documentation and tracking of safety cases and submissions.
• Conduct literature searches and reviews to identify potential safety information and support literature monitoring.
• Manage submission of Individual Case Safety Reports, periodic reports, and related documentation to regulators and stakeholders.
• Support affiliate services activities including safety information exchange, literature screening coordination and translation support.
• Maintain documentation and project files in EDMS and eTMF environments.
• Support regulatory operations by maintaining databases, tracking submissions, and lifecycle management.

Skills

Organization

Attention to detail

Analytical thinking

Pharmacovigilance

Collaboration

Communication

Quality and compliance

Pharmacovigilance systems

Microsoft Office

Education

Bachelor's degree in Life Sciences or related

Tools

Veeva Safety

Job description

Parexel is seeking a Patient Safety Associate I to join its pharmacovigilance team. The role focuses on safety data processing, regulatory submissions, literature screening, and compliance in a global clinical development setting.

You will gain exposure to a broad range of PV processes, collaborating with global teams to support drug safety, regulatory timelines, and high-quality patient safety services while contributing to innovative therapies.