Document & Data Quality Control

RESPONSIBILITIES:

- Conduct QC activities on deliverables ensuring accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations.
- Provides ongoing analysis of data resulting from the quality review of regulatory submission documents/ICSRs/aggregate reports produced by SER, SSRM, Epi, and WRS
- Collaborates with SER authors, epidemiologists, SSRM and others to develop strategies for the creation and collection of metrics data for quality analysis
- Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives
- Supports/promotes accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations
- Provides support for regulatory inspections, internal audits and/or strategic quality initiatives
- Develops and maintains 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
- Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review to SER and SSRM
- Leads and/or participates in quality activities, setting the standard for enhanced collaboration, delivery of project commitments and customer satisfaction
- Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses, and corrective action planning with customers as necessary
- May serve as a subject matter expert working with SER, SSRM, and Epi on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate

QUALIFICATIONS

- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidance
- 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 verbal/written communication and interpersonal skills.
- Demonstrated organizational/project management skills. {m}{c}

SKILLS

Experience with Regulatory Documentation; MUST be detail oriented; Have Background in QA or QC; Have a Pharma Background.

Synectics is an Equal Opportunity Employer.