Global Periodic Reporting Lead

Scorpion Therapeutics; Morristown (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Morristown, NJ is seeking a Senior PSR Lead to ensure robust, compliant Periodic Safety Report processes and vendor oversight. You will mentor the Periodic Report Expert (PRE) Team and drive outsourcing strategies for PSR authoring based on criticality and resourcing needs.

You will establish worldwide regulatory planning for PSRs across the full company portfolio and manage training needs, while acting as system owner for the PSUR Web page repository and tracking tool.

Qualifications

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

Responsibilities

• Ensure and develop robust, compliant PSR processes and vendor oversight.
• Lead the Periodic Report Expert (PRE) Team through coaching and development planning.
• Develop outsourcing strategies for PSR authoring based on business needs.
• Establish and maintain annual worldwide regulatory planning of PSRs for the full company portfolio.
• Manage the PSR Planning Team for planning activities, resources and training.
• Serve as system owner for the PSUR Web page Repository and tracking tool database.
• Identify and implement process improvements to drive efficiency.

Skills

Clinical safety analysis

ICH guidelines knowledge

Global regulatory awareness

Leadership

Project management

Communication

LEAN/Continuous Improvement

Cross-functional collaboration

Education

Bachelor’s degree in health science or related field

Job description

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).