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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 GxP compliance, with a strong focus on leading audits and assessments while driving quality initiatives across global environments. Proven ability to collaborate effectively with senior leaders and stakeholders to enhance training and compliance processes.
Highest-signal resume keywords
PharmacovigilancePharmacovigilance AuditingGxP ComplianceLeadershipAnalytical Problem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Audit PlanningAudit ConductingAudit ReportingCAPA Process ManagementRegulatory Inspection ParticipationTraining DevelopmentStakeholder ManagementAi Capabilities Introduction
Soft Skills
CollaborationLeadership
Industry Keywords
R&DMedical SafetyGlobal ComplianceBusiness-Critical AuditsMatrixed Organization
About the role
Key responsibilities & impact- Collaborate closely with senior leaders across R&D and Medical Safety to drive quality and compliance
- Implement the global compliance audit program to ensure that development programs and processes are in compliance with company standards
- Independently lead the planning, conduct, and reporting of routine and non-routine audits/assessments/inspections
- Manage complex or business-critical audits/issues in a supporting or leading role
- Support the CAPA process following audits
- Participate in regulatory inspections in a leadership role as needed
- Identify training needs and support development and training of auditors
- Lead initiatives and actively participate in key projects across the organization
- Share business area and regulatory knowledge/expertise with stakeholders.
Requirements
What you’ll need- 10 years of experience in Pharmacovigilance
- 3-5 years of experience in Pharmacovigilance Auditing
- Bachelor's degree or equivalent in a relevant field, such as Pharmacy, Sciences, Medical or Bio related
- Proven track record of driving business results through end-to-end collaborative deliverables
- Strong leadership and stakeholder management
- Expertise in PV/GxP expertise, in complex global environments
- Strong analytical, problem-solving skills and introduction of Ai capabilities
- Ability to work collaboratively in a matrixed organization across different backgrounds.
Benefits
Comp & perks- Health and Wellness reimbursements
- Volunteer Days
- Learning & Development Opportunities
- Flexible Work Arrangement
