Pharmacovigilance Compliance Specialist

6 giorni fa


Palombara Sabina, Lazio, Italia CPL TAYLOR by Synergos srl - Ricerca e Selezione Personale Qualificato A tempo pieno

Job Title: Pharmacovigilance Compliance Specialist

Location: Remote Work

Employment Type: Permanent Contract

Salary Range: €50,000-€55,000

CPL & Taylor by Synergos is seeking a Pharmacovigilance Compliance Specialist to manage QAS projects for the delivery of QA GVP services to clients. The ideal candidate will have at least 5 years of experience as a GVP QA Consultant and Auditor, with a strong understanding of GVP regulations and auditing principles.

Responsibilities:

  • Prepare and perform audits on behalf of clients, and relevant reporting to them
  • Assist clients in supporting their Annual Audit plan
  • Collaborate with the QA Director to manage external Auditors and engage them as appropriate
  • Develops the workflow and operational planning for the QA GVP Services provided
  • Ensures that Quality & Projects Plans, are developed according to client requirements
  • Ensures oversight for day-to-day interactions with all staff involved in the services delivery
  • Develops standard operating procedures and work guidance and/or reviews Client's SOPs if applicable, to ensure full compliance
  • Contributes to GVP quality management plans and compliance program
  • Assists clients in audit/inspection readiness
  • Ensures tracking of compliance metrics
  • Assists clients in identifying and up following up on corrective action plans arising from audits and inspections

Requirements:

  • Bachelor's degree in life science disciplines
  • At least 5 years of experience as a GVP QA Consultant and Auditor
  • English, Very good/Fluent
  • GVP regulations
  • Auditing (and related qualification if required)

We Offer:

  • A dynamic and international work environment with opportunities for professional growth
  • Flexible working arrangements to support work-life balance
  • Employment Type: Permanent Contract
  • Salary Range: €50,000-€55,000