Global Periodic Reporting Lead (Pharmacovigilance)

Location: Hybrid in Cambridge, MA; Morristown, NJ; or Swiftwater, PA. US and Puerto Rico residents only.

Salary: $178,500–$257,833.33 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

• Develop and maintain robust, compliant, and controlled processes for Periodic Safety Report authoring and vendor oversight.
• Lead and mentor the Periodic Report Expert Team through coaching, development planning, and training.
• Develop and execute outsourcing strategies for PSR authoring based on business criticality and resourcing needs.
• Manage annual worldwide regulatory planning for PSRs across the clinical and postmarketing portfolio.
• Oversee PSR planning activities, resource allocation, and training needs.
• Own the PSUR web-page repository and tracking-tool database while driving process improvements and efficiencies.

Requirements

• Experience in international pharmacovigilance for marketed drugs and/or clinical development projects.
• Experience compiling and drafting Periodic Safety Reports and safety reports.
• Strong understanding of global PSR regulations, pre- and postmarketing safety reporting, and ICH guidelines.
• Excellent technical, clinical, analytical, written, and oral communication skills.
• Leadership, negotiation, problem-solving, prioritization, process improvement, and project management experience.
• Bachelor’s degree in health science or a related field; fluent English, written and spoken, required.

Culture & Benefits

• Supportive, future-focused R&D environment.
• Opportunities for professional growth through promotion or lateral career moves.
• Rewards package and employee benefit programs.
• Healthcare, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.