Pharmacovigilance, Quality Assurance Officer
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- Ensure quality management of PV deviations (RCA, CAPA, process compliance and timelines).
- Identify quality risks and implement appropriate corrective actions.
- Contribute to PV quality documentation and the annual quality plan.
- Support the Quality Management System (QMS) by monitoring CAPAs, KPI, deviations and changes.
- Participate in audits/inspections and ensure compliance of partners and vendors.
Requirements
- Education: Master's degree in Life Sciences with a specialization in Quality Assurance for Pharmacovigilance (QA-PV) or a Pharmacist degree.
- Experience: Initial experience in pharmacovigilance (PV) and quality assurance (QA) handling PV deviations - ability to assess the adequacy of root cause analyses (RCA) and CAPA plans proposed by stakeholders and to provide QA-PV guidance when needed.
- Skills: Solution-oriented mindset, ability to work in an international environment, strong interpersonal skills. Proactive approach to anticipate issues, identify risks and resolve problems.
- Languages: Excellent written and oral communication skills in English.
Core Competencies
Demonstrates expertise in Quality Assurance for Pharmacovigilance, focusing on managing deviations, conducting root cause analyses, and implementing corrective actions. Proficient in supporting Quality Management Systems and ensuring compliance through effective communication and collaboration.
Highest-signal resume keywords
- Quality Assurance for Pharmacovigilance
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Pharmacovigilance (PV)
- Quality Management System (QMS)
ATS Optimization Keywords
Hard Skills
- Quality Management
- Deviation Management
- Risk Identification
- KPI Monitoring
- Compliance Audits
Soft Skills
- Solution-Oriented Mindset
- Strong Interpersonal Skills
- Proactive Problem Solving
- Ability to Work in International Environment
- Excellent Communication Skills
Industry Keywords
- Pharmacovigilance
- Quality Assurance
- CAPA
- RCA
- Quality Documentation
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