PV RA MW Coordinator/ Experience in Safety Admin

at  Thermo Fisher Scientific

0ANC, Benito Juárez, Mexico -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate11 Sep, 2024Not Specified11 Jun, 2024N/AGood communication skillsNoNo
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Description:

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)

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Information Technology/IT

Pharma / Biotech / Healthcare / Medical / R&D

Information Technology

Graduate

Proficient

1

03840, Ampliación Nápoles, CDMX, Mexico