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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in conducting Good Pharmacovigilance Practice audits and evaluating compliance of investigator sites, CROs, and vendors. Proficient in preparing detailed audit reports and implementing quality assurance plans while ensuring effective communication in English and Mandarin.
Highest-signal resume keywords
Good Pharmacovigilance Practice (GVP) AuditingGood Clinical Practices (GCP) AuditingRegulatory Agency Compliance (FDA, EMA)Quality Assurance Plan DevelopmentB2 Level English and Mandarin Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Quality AssuranceAudit Report WritingCorrective Action Plan ImplementationAudit Program DevelopmentCompliance Evaluation
Soft Skills
Collaborative WorkStakeholder Presentation
Industry Keywords
Good Pharmacovigilance Practice (GVP)Regulatory Agency ExpectationsAudit Readiness ActivitiesQuality Standards
About the role
Key responsibilities & impact- Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- If required will provide corrective actions support and present findings to QA leadership and stakeholders
- Work collaboratively with clients to ensure quality standards.
Requirements
What you’ll need- Minimum 10+ years of Clinical Quality Assurance and/or Good Pharmacovigilance Practice (GVP) experience.
- Minimum 5+ years of Good Clinical Practices auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written
- B2 level in Mandarin communication, verbal and written
- Bachelor's degree
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
