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PEM Manager
2 days ago
Contract
Santa Monica, California, US

Job Description

• Support preparation and maintenance of Risk Management plans
• Contributes to development and execution of post marketing safety studies and/or Risk Evaluation and Mitigation Strategy (REMS), including the associated Elements to Assure Safe Use (ETASU), as applicable
• Support preparation and maintenance of Registry activities in close collaboration with various internal and external functional areas and/or partners
• Participates in cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions with company staff within and external to PVE, to ensure timely advancement of deliverables and submission to health authorities as required
• Support development and/or maintenance of core and local label for Kite products (e.g., CDS, USPI, SmPC, IB, etc)
• Contribute to preparing safety assessments reports
• Participate in preparing responses to safety related requests from health authorities
• Reviews draft periodic reports (e.g., PSUR/PBRER, PADER, DSUR, etc.); may author relevant sections as needed

Job Requirements

ETASU, PSUR/PBRER

 

Job Code: 50112791

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Recruiter Pooja
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Phone +9738412451