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Pharmacovigilance Data Quality Lead

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POST DATE 8/26/2016
END DATE 10/20/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
Primary responsibility is to oversee the quality and compliance of Individual Case Safety Reports (ICSRs) entered into the Shire Global Safety System (SGSS) and ensure systematic documentation of adverse event (AE) data in the SGSS has been entered in accordance with standard operating procedures (SOPs). The incumbent is responsible for Shire s 3rd party case-processing vendor(s) as it relates to quality and compliance of end-to-end case processing activities. Leads initiatives to identify and implement enhancements to improve quality, compliance, productivity and efficiency as case processing activities. Responsible to train and mentor PVRM staff on the use of SGSS to ensure consistency and compliance.

Review 3rd party vendor s case processing quality, coding, seriousness / listedness / causality assessments, narrative writing, and overall consistency and provide quality improvement feedback
Monitor 3rd party vendor s timeliness to ensure compliance to company and global regulatory reporting requirements
Serve as the PVRM single-point of contact for vendor s day-to-day activities and urgently address and/or escalate any issues

Ensure the standardization, quality and consistency of ICSRs to support signal detection activities and aggregate report analysis.
Identify and lead efforts to enhance quality, compliance, productivity and efficiency of case processing activities

Support AE case processing training and mentoring of PVRM staff, including contractors, to ensure AE data is consistent, standardized and of high quality

Management responsibilities include, but are not limited to, oversight of daily activities, goal setting and performance appraisals of direct reports

Serve as subject matter expert for the development of SOPs relating to case processing to ensure consistency, standardization, and compliance to good Pharmacovigilance practices

Bachelor s degree in a science or healthcare related field or a Registered Nurse or other clinical degree is required.
At least 5 years of drug safety experience in a pharmaceutical company with demonstrable skills in AE case processing activities, including data entry, MedDRA coding, narrative writing, and assessment of reportability
Post-graduate qualifications and previous line management experience is desirable.

Domestic and international travel will be required (
May be required to travel domestically and internationally to other Shire sites and CROs to provide training or to external meetings. Driver s license optional but preferred.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.