Global Periodic Reporting Lead

Main Responsibilities:
- Ensure and develop robust, compliant, controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight, upholding regulatory compliance expectations.
- Lead the Periodic Report Expert (PRE) Team through coaching, mentorship, and development planning.
- Develop and execute outsourcing strategies for PSR authoring based on business criticality and resourcing needs.
- Establish and maintain annual worldwide regulatory planning of PSRs for the full company portfolio (clinical and postmarketing).
- Manage the PSR Planning Team for PSR planning activities, resource allocation, and training needs.
- Serve as system owner for the PSUR Web page Repository and tracking tool database.
- Identify, implement, and support process improvements to drive efficiencies and continuous improvement.

Experience/Qualifications:
- Experience in international pharmacovigilance for marketed drugs and/or projects under clinical development.
- Proven transversal collaboration.
- Experience compiling and drafting PSRs and safety reports.

Technical and Soft Skills:
- Excellent technical, clinical, and critical analytical skills with deep understanding of clinical safety processes and analysis.
- Strong understanding of global regulatory framework for PSRs, worldwide pre/postmarketing safety reporting regulations, and ICH guidelines.
- Leadership skills: team motivation, problem-solving, initiative-taking, negotiation.
- Process improvement experience (LEAN/Continuous Improvement) and project management with effective prioritization.
- Excellent written and oral communication skills; computer literacy.

Education/Language:
- Bachelor’s degree in health science or related field.
- Fluent English (written and spoken).