Pharmacovigilance Case Specialist - Global Health Impact

PLG

Philippines

On-site

PHP 480,000 - 800,000

Full time

13 days ago

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Job summary

ProductLife Group Philippines is seeking a Case Specialist (Pharmacovigilance) to ensure high-quality handling of vigilance cases and data entry across client databases. The role requires solid knowledge of GVP/GCP and regulatory requirements as well as strong collaboration with a global team.

The successful candidate will perform medical evaluations, coding, causal assessment, and case closure, while meeting deadlines and maintaining rigorous documentation in post-marketing activities.

Qualifications

  • Doctor in Pharmacy or pharmacist by training.
  • Minimum 3 years in a similar role.
  • Experience meeting deadlines.
  • Pharmacovigilance knowledge and post-marketing case processing.

Responsibilities

  • QC of vigilance cases.
  • Medical evaluation of reports.
  • Data entry of vigilance cases in databases.
  • Follow-up requests by phone/mail.
  • Pre-analysis of complex cases prior to data entry.
  • Causality assessment and coding per dictionaries.
  • Close vigilance files and prepare regulatory documentation.
  • Identify submission requirements and maintain QA for documents.

Skills

Pharmacovigilance
Database experience
GVP/GCP knowledge
Regulatory knowledge
Microsoft Office
Multitasking
Communication skills
Teamwork
Pharmacist

Education

Doctor in Pharmacy

Tools

Microsoft Office
Databases

Job description

ProductLife Group Philippines is seeking a Case Specialist (Pharmacovigilance) to ensure high-quality handling of vigilance cases and data entry across client databases. The role requires solid knowledge of GVP/GCP and regulatory requirements as well as strong collaboration with a global team.

The successful candidate will perform medical evaluations, coding, causal assessment, and case closure, while meeting deadlines and maintaining rigorous documentation in post-marketing activities.

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