Global Pharmacovigilance & Patient Safety Specialist

Parexel; Makati; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Parexel is seeking a Patient Safety Specialist to support global pharmacovigilance activities across clinical trials and post‑market projects. You will help implement safety processes, assist with regulatory submissions, and collaborate with cross‑functional teams to ensure quality and compliance.

The role covers ICSR processing, literature surveillance, safety submissions, and affiliate coordination, with opportunities to contribute to continuous improvement and client satisfaction.

Qualifications

• Knowledge of pharmacovigilance or regulatory regulations and pharmacovigilance processes.
• Ability to interpret regulatory guidelines and safety data.
• Experience with case processing, QA checks, and safety reporting timelines.
• Familiarity with safety databases and regulatory submissions workflows.
• Strong written and verbal communication in a global context.
• Ability to work with cross-functional teams and clients.

Responsibilities

• Support global pharmacovigilance activities across trials and post-market projects.
• Process ICSR workflows, assess cases, and prepare narratives and QC reviews.
• Generate safety reports, listings, and regulatory submissions support.
• Coordinate with affiliates and client teams for timely safety deliverables.
• Assist with literature monitoring, signal review, and safety intelligence.
• Contribute to audits, process improvements, and training activities.

Skills

Pharmacovigilance

Regulatory reporting

ICSR processing

Literature surveillance

Safety submissions

Cross-functional collaboration

Audit & inspections support

Education

Degree in Pharmacy, Nursing, Life Science, or related field

Job description

Parexel is seeking a Patient Safety Specialist to support global pharmacovigilance activities across clinical trials and post‑market projects. You will help implement safety processes, assist with regulatory submissions, and collaborate with cross‑functional teams to ensure quality and compliance.

The role covers ICSR processing, literature surveillance, safety submissions, and affiliate coordination, with opportunities to contribute to continuous improvement and client satisfaction.