Global Periodic Reporting Lead

Scorpion Therapeutics; Pennsylvania; On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking a Periodic Safety Report (PSR) expert leader to oversee PSR authoring, vendor oversight, and global regulatory planning for the company portfolio.

The role leads the PRE Team through coaching and development, develops outsourcing strategies, manages PSR planning resources, and drives continuous improvement in safety reporting processes.

Qualifications

• 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.

Responsibilities

• Ensure and develop robust, compliant, and controlled processes for 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.

Skills

Clinical safety

Analytical skills

Regulatory knowledge

Leadership

Education

Bachelor's degree in health science or related field

Job description

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).