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 via 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 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 drive continuous improvement and efficiencies.

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

Technical/Soft Skills:
- Strong technical, clinical, and critical analytical skills in clinical safety processes.
- Knowledge of global regulatory frameworks for PSRs, worldwide pre-/post-marketing safety reporting, and ICH guidelines.
- Leadership skills (motivation, problem-solving, initiative, negotiation).
- Process improvement experience (LEAN/Continuous Improvement) and project management.
- Excellent written and oral communication; computer literacy.

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

Benefits (if part of the posting):
- Health and wellbeing benefits including healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.