Consultant – Pharmacovigilance Case Processing Lead

Ividata Life Sciences

. Supervise global case management activities across one or more pharmacovigilance platforms .

Posted 9/21/2026full-timeParis • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates extensive expertise in pharmacovigilance, including case processing, regulatory compliance, and quality management. Proficient in managing KPIs, coordinating service providers, and ensuring data integrity within safety databases.

Highest-signal resume keywords

Pharmacovigilance ExperienceCase Processing ExpertiseSafety Database ProficiencyMedDRA Coding SkillsRegulatory Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceCase ProcessingKPI MonitoringMedDRA CodingNarrative WritingData Quality ControlCAPA ManagementAudit ExperienceRegulatory ComplianceAnalytical Thinking

Soft Skills

Attention to DetailOrganizational SkillsCommunication SkillsProactive ManagementCoordination Skills

Tools & Technologies

Argus SafetySafety DatabasesClinical DatabasesPV Systems

Industry Keywords

EMAFDAMHRAPMDAHealth CanadaICH E2BGVPCIOMS PV Guidelines

About the role

Key responsibilities & impact

Supervise global case management activities across one or more pharmacovigilance platforms
Monitor key performance indicators (KPIs) and report on them to Safety leads and Quality teams
Provide hands-on operational support, including case quality review, issue resolution, and day-to-day team guidance
Manage case processing and transmission timelines in accordance with regulatory and contractual requirements
Coordinate and oversee external case processing and literature screening providers
Organize and participate in regular operational meetings with service providers
Reconcile cases with partners and clinical databases (SDEA/PVA)
Contribute to the management of CAPAs, audits, inspections, and quality documents related to case processing
Collaborate with PV systems teams to integrate regulatory intelligence updates into safety databases
Support pharmaceutical and biotechnology clients on high-value projects

Requirements

What you’ll need

Bachelor’s degree or equivalent (minimum three years of higher education) in life sciences, such as pharmacy, medicine, nursing, or a related field
Minimum of 7 years of pharmacovigilance experience, with proven expertise in affiliate case processing
Proficiency with safety databases, such as Argus Safety or an equivalent system
Excellent skills in MedDRA coding, narrative writing, and data quality control
Experience managing outsourced activities and coordinating service providers
Experience monitoring KPIs and managing deviations, CAPAs, audits, and inspections
Knowledge of international regulations and requirements from the EMA, FDA, MHRA, PMDA, and Health Canada
Knowledge of ICH E2B, GVP, and CIOMS PV guidelines and standards
Strong attention to detail, organizational skills, and analytical thinking
Excellent communication and coordination skills
Self-motivated, proactive, and able to manage multiple priorities
Professional proficiency in written and spoken English required

Benefits

Comp & perks

Stimulating and collaborative work environment
High-impact assignments contributing to healthcare innovation
Opportunity to work alongside passionate experts
Cross-functional projects and expanding responsibilities
Continuously evolving environment
Opportunity to make a real impact through your ideas and expertise
Hybrid work