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Document & Data QC
Eingestellt von Synectics
Projektbeschreibung
SKILLS:
- 4-7 years experience in Quality Assurance of regulatory submissions/aggregate reports within the pharmaceutical industry. Knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data.
- Quality Documentation background.
- 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.
- Extensive experience with filing and auditing
- 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
- Knowledge of global regulatory requirements relative to pharmacovigilance, in particular regulatory submission requirements.
- Demonstrated analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills; team player.
- Demonstrated organizational skills.
Projektdetails
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Einsatzort:
Collegeville, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges