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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Pharmacovigilance and GVP Auditing, with a strong focus on compliance, quality assurance, and operational excellence in regulated pharmaceutical environments. Proven ability to lead audits, assess systems, and implement corrective actions while advising clients on Good Pharmacovigilance Practices.
Highest-signal resume keywords
Pharmacovigilance ExpertiseGVP Auditing ExperienceRegulatory Compliance AssessmentQuality Assurance QualificationsAudit Report Writing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
PharmacovigilanceGVP AuditingAudit Strategy DesignRisk AssessmentCompliance Gap AnalysisCorrective Action PlanningDocumentation SkillsQuality ManagementPharmaceutical RegulationsPharmacovigilance Processes
Soft Skills
Analytical SkillsLeadershipClient AdvisoryCommunication
Certifications & Qualifications
Quality Assurance CertificationPharmacovigilance Certification
Industry Keywords
Good Pharmacovigilance PracticesRegulated EnvironmentsHealth Authority InspectionsGlobal PharmacovigilanceMulti-Country Activities
About the role
Key responsibilities & impact- Provide professional leadership and pharmaceutical expertise to clients across pharmacovigilance
- Execute operational tasks and manage technical delivery and projects for pharmacovigilance audits
- Coordinate and perform GVP audits as lead or co-auditor, including process, system, and document audits
- Conduct mock inspections and assist pharmaceutical companies during Health Authority inspections
- Perform pharmacovigilance service provider audits
- Assess pharmacovigilance systems and processes, including interfaces with departments, affiliates, and contract partners
- Manage corrective and preventive action plans
- Act as an external consultant for assessment, quality assurance, and improvement of pharmacovigilance systems and processes
- Review and establish quality management requirements related to pharmacovigilance system setup or maintenance
- Advise clients on Good Pharmacovigilance Practices and legislative compliance
- Design and prepare audit strategies, risk assessments, and audit programs
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Pharmacy, Medicine or a related discipline
- Additional qualifications in Quality Assurance, Pharmacovigilance, or GVP compliance are considered an advantage
- At least 10 years of proven experience in Pharmacovigilance
- At least 5 years of proven experience in GVP auditing
- Demonstrated experience in planning, conducting, documenting, and following up audits
- Experience working in regulated environments within the pharmaceutical industry
- Exposure to global or multi-country pharmacovigilance activities
- Strong knowledge of global and local pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices (GVP)
- Solid understanding of core pharmacovigilance processes
- Ability to assess compliance with regulatory requirements, internal procedures, and quality standards
- Strong analytical skills with the ability to identify compliance gaps, assess risk, and recommend corrective and preventive actions
- Excellent documentation and audit report writing skills
- Fluency in English required; additional languages are an asset
- Availability to travel at least 30% of the time
Benefits
Comp & perks- Benefit offerings outside the US may vary by country and will be aligned to local market practice
- Reasonable accommodations during the employment process for individuals with disabilities