Pv Ra Mw Coordinator/ Experience in Safety Admin

hace 5 meses


Iztapalapa, México Thermo Fisher Scientific A tiempo completo

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.
- 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).


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