Pharmacovigilance Compliance Specialist - new job in Richmond, US

Pharmacovigilance Compliance Specialist
  • Competitive
  • Temporary
  • Richmond VA, US Richmond CHESTERFIELD US
Job Ref: JO000130324
Sector: Clinical
Sub-sector: Quality
Date Added: 01 August 2022

Working as part of the SRG team, the Pharmacovigilance Compliance Specialist will work with a multidisciplinary team to help standardize clinical development and medical affairs/Safety activities within and across programs through preparation of SOPs and personnel training. Specifically, the candidate will develop or oversee the development, maintenance and roll out of processes and procedures to ensure alignment with current best practice guidelines, regulation updates and requirements related to audit corrective actions and a Corporate Integrity Agreement and may assist with training responsibilities. The candidate will support internal and external audits, regulatory inspections, and CAPA plans.

Here’s What You’ll Do:

  • Contribute to the monitoring of the Pharmacovigilance (PV) System to ensure effective processes and regulatory compliance through the compilation and development of the monthly PV System Performance Report

  • Develop and participate in the preparation of PV specific periodic metrics related to Key Performance Indicators, Quality Incident Investigations, CAPAs, audits and inspections outcomes

  • Compile, analysis, and trend pharmacovigilance compliance data including root cause assessments, gap analysis and effectiveness of improvement plans (as necessary)

  • Identify areas for process improvement or possible training requirements and updates

  • Track and trend aspects of the PV Quality System and provide reports to management identifying risks and trends on a routine basis

  • Perform quality control reviews of periodic aggregate safety data and other safety information to assure appropriate level of quality and accuracy

  • Ensure the accuracy, completeness, and audit readiness of PV Metrics, KPIs, and QPIs

  • Support Product Safety & PVG activities for audits and inspection readiness planning and provides ongoing support during the management of internal audits and health authority inspections

  • Monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices

Here’s What You’ll Bring to the Table:

  • Bachelor’s degree in healthcare/scientific related field

  • Minimum of 5 years of relevant experience in Pharmacovigilance/Clinical Research with a minimum of 2 years in PVG compliance and quality

  • A proven track record in pharmacovigilance with several examples of supporting pharmacovigilance related compliance and quality activities

  • Expert knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally

  • Solid experience in quality systems, safety systems and tracking metrics, compliance monitoring

  • Direct experience and knowledge of case processing/ case management and data quality review is required

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

31/08/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Shari Hulitt

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