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Pharmacovigilance Quality Analyst – Mid-Level
Daiichi Sankyo Brasil Ltda. Support the creation, maintenance, and continuous improvement of all aspects of a functional Quality Management System (QMS) for the Pharmacovigilance area, ensuring alignment with regulatory requirements, current good practices, and Daiichi Sankyo’s local, regional, and global requirements.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) within the pharmaceutical industry, focusing on regulatory compliance, continuous improvement, and effective communication with cross-functional teams. Proficient in conducting audits, risk assessments, and providing training on quality standards and practices.
Highest-signal resume keywords
Quality Management System (QMS)Pharmaceutical Industry ExperienceRegulatory Compliance KnowledgeInternal Audits and AssessmentsIntermediate to Advanced English Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk AssessmentAuditingSupplier QualificationData IntegrityCAPAChange ControlGood Documentation PracticesPerformance Indicators MonitoringTechnical SupportQuality Deviations Assessment
Soft Skills
CommunicationTrainingCollaborationProblem-SolvingInterpersonal Skills
Tools & Technologies
Microsoft OfficeWindows
Certifications & Qualifications
Active Professional Registration
Industry Keywords
PharmacovigilanceRegulatory Agencies InteractionQuality StandardsContinuous ImprovementInternational AuditsProcedures and Policies ReviewConsultant Monitoring
About the role
Key responsibilities & impact- Support the creation, maintenance, and continuous improvement of all aspects of a functional Quality Management System (QMS) for the Pharmacovigilance area, ensuring alignment with regulatory requirements, current good practices, and Daiichi Sankyo’s local, regional, and global requirements.
- Support risk assessments, audits, supplier qualification, due diligence, technical agreements, processes and procedural documents, data integrity, CAPA, change control, Quality deviations, good documentation practices, and training.
- Perform activities arising from operational reporting lines, as needed and as delegated by management.
- Generate, document, and monitor performance indicators, with a focus on continuous improvement.
- Establish communication and interfaces with Quality, Regulatory Affairs, Information Technology, Marketing, and Sales.
- Provide interpretation and training on regulatory requirements, good practices, and Quality systems.
- Provide general technical support, including the assessment of Quality deviations, proposed changes, and other technical matters.
- Represent the area in local, regional, and global working groups, including participation in local or international audits and Quality meetings.
- Maintain audit and inspection readiness and participate in audits and inspections conducted at Daiichi Sankyo Brazil.
- Plan, conduct, and document internal audits and assessments.
- Participate in the preparation and review of procedures, policies, standards, and reports.
- Participate in the assessment, selection, support, and monitoring of consultants.
- Contribute to departmental and company objectives and targets.
- Interact with regulatory agencies, business partners, and service providers.
- Perform external activities and travel as needed.
- Plan, monitor, and participate in projects within the areas covered by the QMS.
Requirements
What you’ll need- Bachelor’s degree in Pharmacy, Chemistry, or a related field.
- Experience in the pharmaceutical industry.
- Experience in Quality-related areas and in the specific activities described above.
- Knowledge of relevant national and international regulations.
- Intermediate to advanced English proficiency (reading, comprehension, writing, and speaking).
- Spanish is desirable.
- Computer skills: Windows and Microsoft Office.
- Active professional registration with the relevant professional council is desirable.
Benefits
Comp & perks- Meal and food allowance
- Medical and dental insurance
- Life insurance
- Private pension plan
- Transportation allowance or on-site parking
- Pharmacy benefit
- Profit-sharing bonus
- TotalPass