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Pharmacovigilance Quality Consultant
Eingestellt von Synectics
Gesuchte Skills: Consultant
Projektbeschreibung
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
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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:
Organisation/Management