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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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Audit PlanningAudit ConductingAudit ReportingCAPA Process ManagementRegulatory Inspection ParticipationTraining DevelopmentStakeholder ManagementAi Capabilities Introduction
Soft Skills
CollaborationLeadership
