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Pharmacovigilance Quality Consultant

Eingestellt von Synectics

Gesuchte Skills: Consultant

Projektbeschreibung

Conduct QC review (including verification of data against approved sources) of document deliverables including PSURs, RMPs, responses to regulatory authorities, labels, submission components ensuring accuracy and internal consistency. Analyze data resulting from the quality review of document deliverables. Collaborate with colleagues in generation of document review metrics.

SKILLS:

- BS degree; scientific background; healthcare degree/experience preferred.
- Experience in safety/pharmacovigilance/risk management in the pharmaceutical industry.
- Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry highly desirable.
- Knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data.
- Knowledge of global regulatory submission requirements.
- Demonstrated analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills; team player.
- Demonstrated organizational skills.
- 4-7 years regulatory experience required
- 4-7 years Quality Assurance experience required
- 4-7 years Data Validation experience required
- 4-7 years Regulatory Documentation experience required
- Solid experience in quality review of pharmacovigilance documents and reports submitted to regulators
- Must have experience in a pharmaceutical environment with a strong background in Quality.
- Must also have extensive experience with filing and auditing
- Experience in authoring and/or in QC review of safety sections of PSURs, RMPs, regulatory responses, CTDs
- Experience comparing data and text to sources (such as CSRs or aggregate safety data) in PSURs, RMPs, regulatory responses or CTDs
- Experience with clinical or safety databases

Projektdetails

  • Einsatzort:

    Collegeville, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Organisation/Management

  • Skills:

    consultant

Synectics