Director of Safety, Quality and Standards

Highly Competitive Salary
  1. Permanent
  2. Pharmacovigilance
  3. United States
Cranbury, New Jersey
Posting date: 08 May 2019
DS.BD.23229_1557324636

ProClinical, in support of our client, are seeking an individual to fill the role of Director, Safety, Quality and Standards, based in Cranbury, NJ. The successful candidate will play a pivotal role in providing the strategic direction and compliance leadership to the Global Drug Safety team.

Responsibilities

  • Create and execute GDS Process and Compliance.
  • Lead the development and execution of the GDS Standards and process.
  • Identify potential systemic gaps and coordinate with appropriate stakeholder(s) to ensure timely remediation.
  • As appropriate escalates 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.
  • Monitor and update procedures as necessary based on findings of audits/inspections, CAPA activities, regulatory changes.
  • Help develop and maintain compliance tracking and reporting systems and tools.
  • Interface as necessary with regulatory inspectors to ensure that there is appropriate GDS personal and safety process are communicated during inspections.
  • Create and maintain standardization and oversight of all drug safety activities.
  • Lead the development and implementation of continuous improvement initiatives.
  • Perform and manage quality activities in support of GDS.
  • Ensure that all PMSF activities are accurately represented in the system master file.
  • Assist in the definition of project scope and objectives.
  • Ensure resource availability and allocation
  • Develop a detailed project plan to monitor and track progress
  • Manage changes to the project scope, project schedule, and project costs.
  • Create and maintain comprehensive project documentation.
  • Manage all vendors for GDS to ensure that they are aligned regarding standards and process.
  • Manage resources budget for entire DSS functions across three locations.

Skills and Qualifications

  • BA/BS/MA/PharmD in a biologic/medical/clinical/nursing field (advanced degree preferred).
  • At least 5+ year experience in pharmaceutical industry in drug safety/PV.
  • Experience preparing post marketing safety regulatory documents.
  • Experience with clinical development.
  • Knowledge of US and Ex-US pharmacovigilance risk management regulations
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong knowledge of Microsoft Office suite.
  • Experience with various roles in drug safety.
  • Expertise with PV clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Specific medical writing experience.
  • Project leadership skills with strong organizational and prioritization skills.

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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