Etmf Pv Senior Specialist

Who we are looking for

Purpose

The “eTMF PV Specialist” supports the Global PS Team (within R&D) in the execution and oversight of eTMF activities with regards to Chiesi sponsored GCD and GRD studies.

Main Responsibilities

• Plan all Trial Master File (TMF) activities related to Patient Safety, to guide and oversee providers and to ensure quality and TMF audit / inspection readiness
• Ensure that all the PS documents are archived in accordance with SOPs and study specific characteristics
• Plan TMF activities for the assigned studies and write / review the TMF plan
• Upload documents in the eTMF for documents created internally
• Perform Quality review of documents filed in TMF
• Participate / support audit and inspections to TMF
• Contribute to eTMF process improvement, development of standards and internal system development
• Train the team and external stakeholders on rules and requirements
• Ensure PS documents related to clinical trials are properly stored in the PS common repository
• Review / Contribute to SOPs / Wis related to eTMF management
• Act as Subject Matter Expert of Chiesi eTMF solution
• Maintain compliance with relevant regulations, policies and procedures
• Participate in the internal departmental meetings and project-specific teams
• Represent GPV department in cross-functional corporate teams and project
• Take care about regulatory compliance with regards to clinical trials submissions
• Open and manage GCP deviations in case of issues and manage relative CAPAs

Experience Required

Minimum 8 years of experience in R&D within Pharmaceutical and / or Biotechnology industry / company, with at least 4 years of experience in Pharmacovigilance eTMF management

Education

Master’s degree in science, medicine, biology, pharmacy or related fields, PhD or similar preferred

Languages

Good knowledge of English (both written and spoken)

Technical Skills

• Awareness of EU pharmacovigilance legislation and the principles of global pharmacovigilance requirements including knowledge of PV quality systems and regulatory requirements across US and other countries and regions
• Up-to-date knowledge of local / global CT regulations and respective need for compliance (e.g. Good Clinical Practice)
• Strong technical and problem-solving skills / experience.
• Excellent communication and interpersonal skills
• Ability to work with cross-functional teams, with a clear result-oriented approach
• Demonstrates good initiative, creativity and innovation skills.
• Ability to organize and prioritize tasks both individually and across a team to achieve established deadlines

Soft Skills

• Analytical skills
• Communication skills
• Planning and organizational skills
• Team working

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.