Consultant, Safety Quality and Standards

Highly Competitive Salary
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Cranbury, New Jersey
Posting date: 13 May 2019
DS.BD.23282_1557763741

The successful candidate will play a pivotal role in providing the strategic direction and compliance leadership to the Global Drug Safety team.

Responsibilities

  • Creation and Execution of GDS Process & Compliance
  • Leads the development and execution of the GDS Standards and process
  • Identify potential systemic gaps and coordinate with appropriate stakeholders to ensure timely remediation.
  • Escalate issues of critical noncompliance and/or lack of urgency in remediation to Global Head of Safety.
  • Lead the development and maintenance of Policies, SOPs and work instructions.
  • Continually monitor and update procedures as necessary.
  • Contribute to the development and maintenance of compliance tracking and reporting systems.
  • Develop and distribute compliance reports, as applicable.
  • Develop and manage strategies for preparation for and responses to regulatory agency inspections.
  • Interface as necessary with regulatory inspectors to ensure that there is appropriate GDS personal and safety process are communicated during inspections.
  • Ensure that all documents are produced according to regulatory standards.
  • Create and maintain standardization and oversight of all drug safety activities.
  • Perform and manage quality activities.
  • Coordinate internal resources for the flawless execution of projects.
  • Assist in the definition of project scope and objectives.
  • Develop a detailed project plan to monitor and track progress.
  • Manage changes to the project scope, project schedule, and project costs.
  • Successfully manage relationships with all stakeholders.
  • Perform risk management to minimize project risks.
  • Establish and maintain relationships with third parties/vendors.
  • Create and maintain comprehensive project documentation.
  • Manage all vendors for GDS to ensure that they are aligned regarding standards and process.
  • Support the training and training compliance of all internal and external partners.
  • Manage resources budget for entire DSS functions across three locations.

Skills and Qualifications

  • BA/BS/MA/PharmD with 5+ years of experience in pharmaceutical industry in drug safety/pharmacovigilance (advanced degree preferred).
  • Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans.
  • Experience with clinical development including risk/benefit analysis and safety assessment.
  • Knowledge of US and Ex-US pharmacovigilance risk management regulations.
  • Strong written, verbal, and interpersonal communication skills.
  • Expertise in Microsoft Word, PowerPoint, SharePoint and Excel.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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