Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Compliance Analyst

Eingestellt von Synectics

Gesuchte Skills: Support

Projektbeschreibung

JOB DESCRIPTION:

- Generates integrated compliance data relative to areas of delay (with case processing), trending of aggregate data, root cause analysis and corrective/preventative action planning.
- Liaises with Supplying Organizations and other key external customer groups in support of proactive management of compliance and promotion of corrective action planning activities.
- Assesses timeliness of adverse event reports processed in accordance with relevant guidelines and internal standards.
- Ensures linkages with Supplying Country Organizations, US Supplying Organizations, EU QP Office and Drug Safety Unit management in proactively facilitating compliance and corrective action planning in support of continuous improvement across adverse event (AE) reporting processes.
- Supports the oversight of processes for analytics and reporting of integrated compliance and performance information across AE reporting processes and late reports.

SKILLS:

QUALIFICATIONS:

- Must have experience in regulatory analytical/compliance work and be proficient in Excel
- Two years of experience in the Pharmaceutical industry is required
- Knowledge of global regulatory requirements relative to Pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidance's.
- Bachelor's degree is required.
- Advanced degree desirable.
- Strong technical and Analytical skills and experience ie Excel, Powerpoint, and other analytical applications.
- The candidate should also have knowledge on Pharmaceutical and Regulatory experience.

Projektdetails

  • Einsatzort:

    Gladstone, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Synectics