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