Pharmacovigilance / Drug Safety Review Specialist | Metro Manila

4 days ago

Manila, National Capital Region, Philippines Private Advertiser Full time ₱900,000 - ₱1,200,000 per year

Key Responsibilities

  • Collect, evaluate, and process adverse event (AE) reports from various sources including clinical trials, healthcare providers, and literature.
  • Conduct medical reviews and causality assessments using tools like MedDRA and WHO Drug Dictionary.
  • Prepare and review safety narratives, periodic safety update reports (PSURs), and risk management plans.
  • Ensure compliance with international and local pharmacovigilance regulations (e.g., ICH, FDA, EMA).
  • Collaborate with cross-functional teams including regulatory affairs, clinical operations, and medical affairs.
  • Participate in audits, inspections, and training of new team members.
  • Maintain up-to-date knowledge of product safety profiles and regulatory requirements.

Qualifications

  • Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related field.
  • 2–5 years of experience in pharmacovigilance or drug safety.
  • Strong knowledge of adverse event reporting, safety databases (e.g., ARISg), and regulatory guidelines.
  • Excellent analytical, communication, and organizational skills.
  • Proficiency in MS Office and pharmacovigilance software tools.
  • Certification in Pharmacovigilance is a plus.

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