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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 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 activities, including SAE/SUSAR management and compliance with regulatory standards. Proficient in data management and reporting, with strong organizational and communication skills.

Highest-signal resume keywords
Pharmacovigilance ExperienceICSR ProcessingMedDRA CodingAdvanced English ProficiencyMS Office Literacy

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
ICSR ProcessingSAE ManagementMedDRA CodingDatabase ReportingClinical Trial ReconciliationSafety Management Plan ReviewProduct Quality Complaint HandlingData Protection ActivitiesPharmacovigilance ProcessesWorkflow Management
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Industry Keywords
Life SciencePharmacyHealthcareClinical TrialsQuality AssuranceMedical InformationClient ReportingSafety ManagementRegulatory CompliancePharmacovigilance

About the role

Key responsibilities & impact
  • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client 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 data for monthly client reporting
  • Support workflow and resource management
  • Support ICSR-related pharmacovigilance processes for PrimeVigilance and clients
  • Perform tasks assigned to more junior positions as applicable for a senior colleague
  • Support the RA & PV Network Department as needed
  • Act as LCPPV for a specified country when assigned
  • Act as PRLS for a designated language when assigned

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
  • Advanced spoken and written English
  • Advanced literacy in MS Office

Benefits

Comp & perks
  • Remote work option
  • Flexible work environment
  • Growth opportunities
  • Collaborative and supportive team culture
  • Diverse and inclusive workplace
  • Opportunity to work with global teams
  • Meaningful work contributing to patient safety
  • Exposure to clinical research, pharmacovigilance, and quality consulting
  • Passionate and collaborative team of experts