Description
Title: Contractor - Document and Data Quality Control, WSRO, Quality Standards & Training
Role Description:
Conduct QC activities on deliverables produced by SER, Epi, SSRM, QST and Clinical ensuring accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations.
Responsibilities:
- Provides quality control review of data from Epi, QST, SER, SSRM, and clinical sources.
- Collaborates with SER authors, epidemiologists, SER Management and others to develop strategies for the creation and collection of metrics data for quality analysis
- Support/promote accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations
- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidance
- Support of regulatory inspection, internal audits and/or strategic quality initiatives
- Develop and maintain an understanding of ARGUS and case processing activities so as ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses, and safety query responses
Qualifications:
In general, candidates should have the following levels of education/experience/attributes:
- BS degree (or equivalent).
- Three (3) years minimum experience in the clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
- Experience in quality control and/or quality assurance within the pharmaceutical industry highly desirable.
- Knowledge of pharmacovigilance, global safety regulations, and guidelines, or equivalent
- Demonstrated strength in analytical skills and attention to detail
- Demonstrated strength in oral/written communication and interpersonal skills
- Demonstrated organizational/project management skills
MUST HAVE AT LEAST A BACHELOR'S DEGREE.
Required Skills/background: QA, QC
Most Critical Skills: Extreme attention to detail, knowledge of pharmacovigilance.
NO OVERTIME OR TRAVEL REQUIRED.
SKILLS
Quality Assurance, Quality Control, Regulatory Experience
Synectics is an Equal Opportunity Employer.