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ERGOMED

Senior PV Associate

ERGOMED

. Provide support to other activities undertaken by the project team on behalf of the client and the company .

Posted 11/10/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in pharmacovigilance processes, including ICSR management, MedDRA and WHO coding, and compliance with regulatory standards. Proficient in data management and reporting, with strong organizational and management skills to support project activities effectively.

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

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
ICSR ProcessingSAE/SUSAR ManagementClinical Trial ReconciliationProtocol ReviewSafety Management Plan ReviewData AnalysisDatabase Output ProductionPharmacovigilance ComplianceProduct Quality Complaint HandlingPersonal Data Protection
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Tools & Technologies
MS Office
Industry Keywords
Life ScienceHealthcareQuality AssuranceMedical InformationClinical Safety

About the role

Key responsibilities & impact
  • Provide support to other activities undertaken by the project team on behalf of the client and the company
  • Perform activities within the ICSR management unit within agreed scope and timeframe
  • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements and timelines
  • Perform ICSR follow-up, SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review
  • Perform clinical and partner reconciliation
  • Handle personal data protection and Product Quality Complaints
  • Interact with Quality Assurance and Medical Information teams
  • Perform MedDRA and WHO coding
  • Produce database outputs and reports, including data for monthly client reporting
  • Support workflow and resource management
  • Support pharmacovigilance processes for PrimeVigilance and clients
  • 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
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
  • Equal opportunities workplace
  • Human-centric environment
  • Support for employee experience, well-being and mental health
  • Healthy work-life balance