Senior PV Associate

ERGOMED

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

Posted 9/22/2026full-timeRemote • Bulgaria, New ZealandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in ICSR management, including processing Individual Case Safety Reports and compliance with regulations. Proficient in pharmacovigilance processes, data protection, and effective communication with cross-functional teams.

Highest-signal resume keywords

ICSR ManagementPharmacovigilance ProcessesMedDRA and WHO CodingAdvanced English ProficiencyMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICSR ProcessingSAE/SUSAR ManagementClinical Trial ReconciliationSafety Management Plan ReviewDatabase ReportingData Protection ManagementProduct Quality Complaint HandlingPharmacovigilance ComplianceProtocol ReviewWorkflow Management

Soft Skills

Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management

Industry Keywords

Life SciencePharmacyHealthcarePharmacovigilanceMedical InformationQuality AssuranceClient ReportingSOPsLCPPVPRLS

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 ICSR management activities within agreed scope and timelines
Process Individual Case Safety Reports from all sources in compliance with applicable regulations, company procedures and client-specific requirements
Perform ICSR follow-up, SAE/SUSAR management, including unblinding, clinical trial reconciliation and protocol review
Review Safety Management Plans
Perform clinical and partner reconciliation
Manage personal data protection activities
Handle Product Quality Complaints and interact with Quality Assurance
Interact with Medical Information teams
Perform MedDRA and WHO coding
Produce database outputs and reports, including monthly client reporting data
Support workflow and resource management
Support pharmacovigilance processes related to ICSR management for PrimeVigilance and clients
Perform tasks assigned under SOPs to more junior positions when applicable
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

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
Employee experience, well-being and mental health support
Excellent training and development platform
Healthy work-life balance