Randstad Pharmacovigilance in Lexington, Massachusetts

Pharmacovigilance

job details:

  • location:Lexington, MA

  • salary:$44.39 - $52.22 per hour

  • date posted:Monday, May 21, 2018

  • job type:Contract

  • reference:25120

job description

Pharmacovigilance

PV Scientist Doc. Management Specialist III

Job Summary

The PV Scientist Operations Specialist will be required to edit, format, and perform quality control (QC) checks of PV documents intended for submission to regulatory agencies. This role will also require that the PV Scientist Operations Specialist provide additional PV Scientist Support in accordance with company SOPs and processes.

Job Responsibilities

  • Edit, format, and perform QC checks of PV Aggregate Reports, Safety Topic Reports, and Quality Incident Reports intended for submission to regulatory agencies.

  • Edit and format ad hoc documents as appropriate

  • Communicate with document authors to meet timelines

  • Review documents in accordance with Shire SOPs, company defined templates, Shire Style Guide, and existing finalization and QC processes

  • Ensure documents are securely maintained and version controlled to maintain the integrity of documents in accordance with Shire SOPs and processes

  • Importing of documents to the document management system and formatting documents to comply with submission-ready standards

  • Perform reviews of hyperlinks and bookmarks on published clinical documents

  • Support the coordination, collecting, importing, and submission readiness of PV Report appendices

  • Ensure adherence to defined document naming standards across all PV documents to be located in Shire's Electronic Document Management System

  • Support the PV Scientists Teams in the preparation of internal and external audits, including regulatory agency inspections

  • Assist in the technical and scientific support for safety surveillance and signal detection activities for Shire products.

  • Assist the PV Scientist in regulatory commitments to ensure the risks described in the product Risk Tracking Documents and IVEA are efficiently and accurately tracked in the most current versioning of MedDRA

  • Assist the PV Scientists in various tasks to include: production of biweekly clinical line listiings, SAE Reconciliaton of clinical trials, biannual review of AE Questionaires in accordance with current Risk Management Plans

  • Support the PVRM TA Heads in the maintainance of physician eRoom meeting materials, presentations, and product information files on Sharepoint

Education & Qualifications

Preferred

  • Typically 3-5 years in the pharmaceutical industry and specifically within

  • Pharmacovigilance or a regulatory operations function preferred

  • Previous hands-on experience with submission of documents preferred

  • Ability to multitask and work under strict time constraints

  • Ability to adapt quickly to changing business and healthcare needs, and to be autonomous, while working in consultation with the PV Scientist Leads, PV Scientists, PVRM Physicians, document reviewers and approvers, and Leadership and other functional area representatives within R&D

Essential

  • Life Science Degree or Healthcare Professional

  • Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat

  • Meticulous attention to detail

  • Excellent written English skills

  • Ability to review documents for quality and compliance

  • Ability to work independently and as an integral part of a team, take initiative, and complete tasks to deadlines

  • Ability to manage multiple activities, prioritize effectively, and work to aggressive timelines

  • Flexibility to work in an ever-changing environment

  • Experience in the use of Documentum or similar Electronic Document Management system

  • Experience with Microsoft Excel and PowerPoint

  • Experience working in Safety Databases

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.