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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, with a strong focus on compliance, data protection, and quality assurance. Proficient in MedDRA and WHO coding, with advanced organizational and management skills to support workflow and resource management.

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
ICSR Follow-UpSAE/SUSAR ManagementClinical Trial ReconciliationSafety Management Plan ReviewDatabase ReportingPharmacovigilance ProcessesProduct Quality Complaints HandlingMedical Information InteractionAttention to DetailMultitasking
Soft Skills
Organization SkillsTime ManagementIssue Management
Tools & Technologies
MS Office
Industry Keywords
Life ScienceHealthcare QualificationPharmacovigilance RegulationsQuality AssurancePersonal Data Protection

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 activities
  • Manage SAE/SUSAR activities, including 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 monthly client reporting data
  • Manage workflow and resources
  • Support pharmacovigilance processes for PrimeVigilance and 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 a specified country and PRLS for a 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 environment
  • Growth opportunities
  • Collaborative and supportive team culture
  • Global reach and international work environment
  • Belonging-focused workplace
  • Opportunity to contribute to patient safety and pharmaceutical treatment outcomes