Global Patient Safety Specialist

Parexel International; Makati; On-site; PHP 800,000 - 1,200,000; Full time

Job summary

Parexel International is seeking a Patient Safety Specialist to support global pharmacovigilance activities across clinical trials and post-marketed projects. You will contribute to safety processes with growing autonomy, handling ICSR processing, safety submissions, literature surveillance, and cross-functional coordination with clients.

The role requires knowledge of PV regulations, strong analytical abilities, and excellent communication.

Qualifications

• Knowledge of pharmacovigilance regulations and PV processes.
• Experience with safety databases and data analysis.
• Familiarity with ICH guidelines and regulatory requirements.

Responsibilities

• Support global pharmacovigilance activities across trials and post-marketed projects.
• Execute ICSR processing workflows and assist with case assessment.
• Prepare case documentation including narratives and QC.
• Generate safety reports and listings for internal/external stakeholders.
• Assist with regulatory submissions and literature surveillance.
• Collaborate with affiliates and cross-functional teams to ensure timely safety deliverables.

Skills

Pharmacovigilance knowledge

Analytical problem-solving

Effective communication

Organizational skills

PV systems knowledge

Education

Degree in Pharmacy or Life Science

Tools

Safety databases

Job description

Parexel International is seeking a Patient Safety Specialist to support global pharmacovigilance activities across clinical trials and post-marketed projects. You will contribute to safety processes with growing autonomy, handling ICSR processing, safety submissions, literature surveillance, and cross-functional coordination with clients.

The role requires knowledge of PV regulations, strong analytical abilities, and excellent communication.