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PV RA MW Coordinator/ Experience in Safety Admin
Pharmaceutical Product Development (PPD)
Mexico City, Mexico
Job Description
PV RA MW Coordinator
• Provides support and coordination of review of safety and regulatory publishing documents on receipt.
• Assists in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.
• Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.
• Assists in maintaining the upkeep of licenses within internal and/or external systems for users across projects within IT Security standards.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts minutes/materials to client portals and distributes to internal and external project teams.
• Manages project specific training and the set-up, maintenance and archival of program files; ensuring audit readiness.
• Identifies and redacts subject and client confidential identifiers per local requirements, retrains sites and escalates reoccurrences to PPD Data Privacy.
• Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.
• Oversees expenses and manages translations; ensuring budget parameters are not exceeded.
• Assist with archiving of regulatory publishing documents and submissions.
Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Job posted: 2024-03-18