Senior Manager, Kite Safety and Pharmacovigilance

仕事内容

The Senior Manager, Kite Safety and Pharmacovigilance provides scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products. This role serves as a senior pharmacovigilance science expert, leading complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution.

Key Responsibilities

Aggregate Reporting and Medical Writing

• Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical context

• Author and review high-impact safety documents supporting regulatory submissions and lifecycle management

Safety Analysis and Signal Management

• Lead safety reviews, including design of search strategies, data evaluation methodologies, and scientific interpretation of individual and aggregate safety data

• Review individual case safety reports to identify and assess potential safety signals and support signal detection and management activities in accordance with procedural documents

Regulatory and Health Authority Engagement

• Prepare and lead responses to safety-related requests from global health authorities, including responses to questions, filing support, and Data and Safety Monitoring Board requests

• Support development and maintenance of product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure

Cross-Functional Leadership and Compliance

• Serve as Pharmacovigilance Science Safety Lead for products in development, partnering closely with Clinical, Regulatory, Medical Affairs, and other stakeholders

• Provide safety content for clinical protocols, clinical study reports, informed consent forms, and other development and post-marketing documents

• Ensure compliance with global regulations and internal procedures; support audits and inspections and contribute to inspection readiness activities

Basic Qualifications:

MD with 0+ years of relevant experience

OR

Doctorate with 2+ years of relevant experience

OR

Master’s degree with 6+ years of relevant experience

OR

Bachelor’s degree with 8+ years of relevant experience

Preferred Qualifications, Experience, and Skills:

• 5+ years of direct pharmacovigilance experience performing aggregate reporting, safety analysis, and regulatory support activities

• Strong knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines

• Experience working with safety databases and tools, including Argus, Rave, MedDRA, and WHO Drug

• Demonstrated ability to independently lead complex safety deliverables and make sound scientific judgments

• Excellent written and verbal communication skills, with strong medical writing capability

• Proven ability to collaborate effectively across functions and cultures and to lead within matrixed project teams