Drug Safety Specialist

5 hours ago


Manila, National Capital Region, Philippines Sysgen RPO, Inc. Full time
Remote job opportunity available for a Pharmacovigilance Specialist with a strong background in pharmacy and relevant experience.

Pharmacovigilance Specialist will be responsible for collecting, monitoring, and evaluating safety information, collaborating with various stakeholders, and handling safety mailboxes. The role requires independent judgment to troubleshoot and resolve project issues, identify areas for improvement, and mentor new team members. The Specialist will also review regulatory and pharmacovigilance publications, maintain medical understanding of therapeutic areas, and participate in departmental initiatives.

  • Collect, monitor, and evaluate safety information
  • Collaborate with project team members, customers, and third-party stakeholders
  • Handle safety mailboxes through email and/or tools
  • Exercise independent judgment to troubleshoot and resolve project issues
  • Mentor new team members
  • Review regulatory and pharmacovigilance publications
  • Maintain medical understanding of therapeutic areas
  • Participate in departmental initiatives
  • Ensure compliance with regulatory bodies, affiliates, and partners
  • Monitor company-sponsored digital media
  • Act as case owner for assigned Individual Case Safety Reports (ICSRs)
  • Conduct timely literature searches
  • Perform quality review and follow-ups
  • Support audits and inspections
  • Maintain up-to-date trackers and formats
  • Maintain high standards of case quality
  • Assist with reconciliation of adverse event reports
  • Manage and prioritize individual workload
  • Handle and manage Eudravigilance and health authority reports
  • Contribute to SOP development and PV training
  • Highlight safety-related issues to management
  • Perform other ad-hoc PV activities as required
  • Stay up-to-date with changes to PV legislation
  • Meet agreed Key Performance Indicators (KPIs)

Qualification:

  • Pharm D/Post Graduation in Pharmacy or equivalent
  • 3+ years of relevant experience


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