Global Periodic Reporting Lead

Main Responsibilities:
- Ensure and develop robust, compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight.
- 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 entire company portfolio (clinical and postmarketing).
- Manage PSR Planning Team 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 leverage efficiencies and drive continuous improvement.

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

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

Education:
- Bachelor’s degree in health science or related field.

Language:
- Fluent English (written and spoken).