Randstad Pharmacovigilance in Cambridge, Massachusetts

Pharmacovigilance

job details:

  • location:Cambridge, MA

  • salary:$39.57 - $46.55 per hour

  • date posted:Friday, July 13, 2018

  • job type:Contract

  • reference:25794

job description

Pharmacovigilance

PV Compliance & Training Manager I

True Title: GDS Compliance Process and Standards

Job Summary

Please note this is NOT a training role. True job title is GDS Compliance Process and Standards (GxP regulations, SOPs). This is a 6-month role

Job Responsibilities

  • Review of existing policies, standard operating procedures (SOPs), job aids, training content and other types of controlled documents to identify gaps and inconsistencies for Global Drug Safety (GDS) within R&D, documentation of findings, and assist with updates to the documents as required.

  • Review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.

  • Perform Quality Control reviews on process document content and formatting to identify any gaps.

  • Maintain the documentation related to gaps identified in the procedural documents.

  • Work with subject matter experts and key functional department personnel to ensure accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified.

  • Maintain and coordinate activities related to the document update using the electronic document management system (EDMS) including document initiation, workflow support, revision, and retirement, as required.

Education & Qualifications

  • Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry

  • Direct experience in GXP-compliant quality systems is preferred

  • Experienced in Microsoft office applications specifically Word, Excel and Visio

  • Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes

  • Excellent communication skills including: technical writing, interpersonal and

  • collaborative skills

  • Excellent organization skills with the ability to stay accountable to deliverables and milestones

  • Ability to thrive and multi-task in a fast-paced environment

  • Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles

  • Must work effectively in a team environment and with individuals at all levels within an organization.

  • This is a 6 month contractual opportunity.

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.