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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

Use this summary to align your resume positioning with the role.

Demonstrates expertise in processing Individual Case Safety Reports (ICSRs) in compliance with regulations and client requirements, along with strong organizational and management skills. Proficient in pharmacovigilance processes, including MedDRA and WHO coding, and capable of acting as Local Contact Person for Pharmacovigilance.

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Individual Case Safety Report ProcessingMedDRA CodingWHO CodingSafety Management Plan ReviewClinical Trial ReconciliationProduct Quality Complaint HandlingData Protection ActivitiesDatabase ReportingWorkflow ManagementPharmacovigilance Processes
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Industry Keywords
PharmacovigilanceLife SciencesHealthcareClinical TrialsSafety ManagementQuality AssuranceLocal Contact Person for PharmacovigilancePerson Responsible for Local Screening

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 SAEs/SUSARs, 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 related to ICSR management within PrimeVigilance and for clients
  • Perform tasks assigned to more junior positions, where applicable for a more senior colleague
  • Support the RA & PV Network Department as needed
  • Act as LCPPV for the specified country and PRLS 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
  • Advanced English, spoken and written
  • Advanced literacy in MS Office
  • Ability to act as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country, as agreed with the line manager
  • Ability to take on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Benefits

Comp & perks
  • Remote work option
  • Flexible work environment
  • Growth opportunities
  • Collaborative team environment
  • Belonging and inclusive culture
  • Opportunity to work on global pharmacovigilance projects
  • Professional development through work with clinical research, pharmacovigilance, and quality consulting experts