Pv Ra Mw Coordinator

1 month ago

Remote, India Thermo Fisher Scientific Full time

Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.
- Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial master files.
- Takes responsibility for maintaining the confidentiality and integrity of sensitive information, meticulously ensuring the redaction of Commercially Confident Information and Personal Data for regulatory publishing.
- Assists in the maintenance of licenses across projects, ensuring compliance with IT Security standards and facilitating smooth operations for users.
- Takes charge of coordinating and facilitating project meetings, ensuring effective communication and collaboration among team members.
- Demonstrates exceptional organizational skills by managing project-specific training, setting up and maintaining program files, and ensuring audit readiness.
- Performs accurate and efficient data entry into various databases and tracking systems, including PPD's budget management system, ensuring project timelines are not compromised.
- Takes ownership of overseeing expenses and managing translations, ensuring adherence to budget parameters and cost-efficiency.
- Assists in the essential task of archiving regulatory publishing documents and submissions, contributing to the seamless flow of information and compliance.

  • PV RA MW Coordinator

    7 days ago

    Remote, India Thermo Fisher Scientific Full time

    Job Description• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.• Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial...

  • PV RA MW Coordinator

    3 days ago

    Remote, India Thermo Fisher Scientific Full time

    Job Description• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.• Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial...

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  • PV Manager

    1 month ago

    Remote, India Thermo Fisher Scientific Full time

    Job DescriptionCoordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project...

  • PV Manager

    1 month ago

    Remote, India Thermo Fisher Scientific Full time

    Job DescriptionCoordinates contracted safety responsibilities for one or more programs, including staffing, training, and  procedural compliance. Manages the safety team on respective programs. Works with senior  management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the...

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    2 months ago

    Remote, India Thermo Fisher Scientific Full time

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  • Safety Specialist

    2 months ago

    Remote, India Thermo Fisher Scientific Full time

    Job DescriptionPerforms day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance...

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    REMOTE, India Parexel Full time

    Management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area :Lead and work independently and as part of the QA team Act as expert GxP consultant in relevant area to groups within the Parexel organization and Parexel clients. Promote compliance within the company and represent QA, as required....

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