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ERGOMED

Senior Pharmacovigilance Associate

ERGOMED

. Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements, and timelines .

Posted 9/15/2026full-timeRemote • New ZealandSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in processing Individual Case Safety Reports (ICSRs) and managing pharmacovigilance processes, ensuring compliance with regulations and client-specific requirements. Proficient in MedDRA and WHO coding, with strong organizational and management skills to support workflow and resource management.

Highest-signal resume keywords
Pharmacovigilance ExperienceICSR ProcessingMedDRA CodingData ReportingAdvanced English Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
ICSR ProcessingMedDRA CodingWHO CodingData ReportingClinical Trial ReconciliationSafety Management Plan ReviewProduct Quality Complaint HandlingPersonal Data ProtectionPharmacovigilance ProcessesDatabase Output Production
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Tools & Technologies
MS Office
Industry Keywords
Life SciencePharmacyNursingHealthcare QualificationSAE ManagementSUSAR ManagementQuality Assurance InteractionMedical Information InteractionRA & PV Network SupportLCPPV Role

About the role

Key responsibilities & impact
  • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements, and timelines
  • Perform ICSR follow-up, including SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
  • Perform clinical and partner reconciliation
  • Handle personal data protection activities
  • Handle Product Quality Complaints and interact with Quality Assurance
  • Interact with Medical Information
  • Perform MedDRA and WHO coding
  • Produce database outputs and reports, including data for monthly client reporting
  • Manage workflow and resources
  • Support pharmacovigilance processes within PrimeVigilance and for clients
  • Perform tasks assigned to more junior positions as appropriate for a senior colleague
  • Support the RA & PV Network Department as needed
  • Act as LCPPV for the specified country as agreed with the line manager
  • Take on the PRLS role for the designated language as agreed with the line manager

Requirements

What you’ll need
  • Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
  • Minimum 1 year of work experience in pharmacovigilance
  • Organization skills, including attention to detail and multitasking
  • Management skills, including time and issue management
  • English - advanced (spoken, written)
  • Advanced literacy (MS Office)

Benefits

Comp & perks
  • Remote work option
  • Flexible work culture
  • Growth opportunities
  • Collaborative and supportive team environment
  • Global work environment
  • Belonging and inclusive culture
  • Opportunity to contribute to patient safety
  • Work with experts in clinical research, pharmacovigilance, and quality consulting