Description
RESPONSIBILITIES:- Conduct QC review (including verification of data against approved sources) of document deliverables including responses to regulatory authorities, labels, submission components, ensuring accuracy and internal consistency.
- Provide ongoing analysis of data resulting from the quality review of document deliverables.
- Collaborate with colleagues in generation of document review metrics.
Regulatory Documentation, Quality Assurance, Regulatory experience required. Experience in safety/pharmacovigilance/risk management in the pharmaceutical industry. Knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data. 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.
Education:
Certification - Medical Technology at Medical College; Bachelor of Science in Biology. Over 15 years' experience in pharmaceutical environment with strong background in Quality. Operational knowledge of Pharmaceutical Regulations (21 CFR and Eudralex) including cGMPs, GCPs, GLPs and GTPs. Extensive experience with filing and auditing activities for both drug and vaccine programs. Highly results oriented with excellent leadership, organizational and communication skills.
Regulatory Audit Experience:
Technical Experience:
PC and Macintosh Word Processing experience including: Word, Excel, Access, PowerPoint, Project, Outlook, Adobe and Visio programs. Extensive database experience to include oracle databases and other document management systems. WebEx/Netmeeting/Live Meeting and other video web conferencing programs. Web page support and development, Computer Programming certification. Laboratory Information Management Systems (LIMS). Healthcare degree/experience preferred. Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry highly desirable.
Synectics is an Equal Opportunity Employer.