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.

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.

Pharmacovigilance Auditor, Manager

Key skills