Remote PharmD Drug Safety & Pharmacovigilance Specialist

Private Advertiser; Taguig; Remote; PHP 600.000 - 1.000.000; Vollzeit

Benefits dieser Stelle

Career growth

Competitive benefits

Global exposure

Zusammenfassung

Private Advertiser is seeking a Pharmacovigilance Specialist (PharmD) to provide medical review and clinical oversight for drug safety cases in a fully remote role. You will ensure accuracy, quality, and regulatory compliance of PV activities while collaborating with global stakeholders.

Responsibilities include reviewing ICSRs, assessing adverse events, ensuring regulatory compliance, and acting as a subject matter expert for complex drug safety cases.

Qualifikationen

• Doctor of Pharmacy (PharmD) with strong experience in medical review of ICSRs.
• Excellent English verbal and written communication skills.
• Ability to work in a global, cross-functional environment and ensure regulatory compliance.

Aufgaben

• Review and validate ICSRs and medical safety data.
• Assess adverse event reports and medical narratives for accuracy.
• Ensure scientific, clinical, and regulatory quality of pharmacovigilance deliverables.
• Provide medical expertise for safety assessments and risk evaluations.
• Identify potential safety signals and support benefit-risk analyses.
• Collaborate with PV, Regulatory Affairs, Clinical Operations, and Quality teams.
• Support compliance, audits, and quality improvements.
• Serve as SME for complex drug safety cases.

Kenntnisse

Medical review

English comms

Regulatory knowledge

Cross-functional collaboration

Ausbildung

PharmD in Medical Sciences

Tools

Argus Safety

Veeva Safety

Jobbeschreibung

Private Advertiser is seeking a Pharmacovigilance Specialist (PharmD) to provide medical review and clinical oversight for drug safety cases in a fully remote role. You will ensure accuracy, quality, and regulatory compliance of PV activities while collaborating with global stakeholders.

Responsibilities include reviewing ICSRs, assessing adverse events, ensuring regulatory compliance, and acting as a subject matter expert for complex drug safety cases.