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job location Job Location:

Milan, Italy

 

PhV Consultant

Requested Languages:

English
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job at pqe

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com. Due to a constant growth, PQE is looking for a new Pharmaceutical Executive Consultant. The PQE Pharmacovigilance Centre offers the most comprehensive services dedicated and tailored to Sponsors, CROs, PhV Service Providers and MAH. Our service excellence is achieved through a team with more that 10 years experience on this field. Our Experts are PhV Specialists, Medical Doctors and technicians, who have a deep knowledge in Pharmacovigilance processes, Systems, Quality Systems in regulated environments. PQE is committed to patient safety and is ready to collaborate with clients to meet the increasingly complex regulatory requirements in Pharmacovigilance. Through efficiencies, maintaining quality and adhering to regulations, PQE creates value across all areas of pharmacovigilance.



    Responsibilities:
    • Full support in establishing, reviewing, updating customers’ Quality System:
    • Service provider for MAH and Vendors
    • SOPs/Policies Development and Issuing
    • Procedures and Working Standards Review
    • GAP analysis of the quality System vs EU GVP
    • Process mapping
    • Pharmacovigilance System Master File issuing and review
    • Safety Data Exchange Agreement issuing and review
    • PSMF creation and review
    • Risk management plan review
    • Third-Party Audits to:
    • Pharmacovigilance Suppliers (Qualification, Follow Up, For Cause)
    • PhV Computer System providers
    • PhV Database in «Hosting»
    • Affiliates
    • MAHs
    • Specific Auditing Services:
    • Pharmacovigilance Documents and Agreements
    • PSMF
    • SDEA
    • Support on Validation Life Cycle for Pharmacovigilance Computerized Systems:
    • Pharmacovigilance Database
    • AERS
    • ARISg
    • ARGUS
    • PcV Manager
    • PSMF Manager
    • Data Migration Validation
    • Trainings Execution and Material preparation:
    • PV Quality Management System
    • GVP Compliance
    • E-Learning design (Material preparation and Effectiveness Checks design)
    • Inspection preparation and support:
    • Inspection readiness
    • Support during Inspections (back and war-room)
    • Post inspection Follow-up, CAPA definition and implementation
    Requirements:
  • Technical degree (Medicinal Chemistry, Biology, Pharmacy, etc)
  • 3+ years of experience in Pharmacovigilance area
  • 1+ years of experience in PV quality assurance activities, in particular in PV auditing activity.
  • Knowledge of GVP regulation as well as 21 CFR and other applicable regulations.
  • Excellent interpersonal relations and written and verbal communication skills
  • Proven organizational skills with ability to manage multiple priorities in parallel
  • Flexible, adaptable, and able to react to changing circumstances and priorities
  • Displays a high level of commitment and professionalism
  • Maintains a ‘can-do’ attitude, collaborates effectively and contributes to a team-oriented culture; possesses strong work ethic and integrity
  • Fluent English
Full-Time Job

If interested, please send your resume in English to job-opportunities@pqe.com Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe