Graps Patient Safety Operations, Post Marketing Manager

GRAPS Patient Safety Operations, Post Marketing Manager
Date: 26 Sept ****
Department: Global Regulatory Affairs & Patient Safety
Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Europe, remote, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.
More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.
This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
This fosters a culture of reliability, transparency, and ethical behaviour at every level.
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are.
We believe our differences make us stronger.
We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business.
It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.
Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
This is what you will do
Play a key role in safeguarding patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi's global portfolio.
You will ensure the quality, compliance, and integrity of safety data, collaborate with international stakeholders, and drive continuous improvement, inspection readiness, and operational excellence across global Patient Safety processes.
You will be responsible for
Support the GRAPS Safety Operations PM Head in ensuring that all current requirements for these activities are effectively incorporated into Chiesi processes and documented in procedures
Ensure data collection in alignment with the safety strategy for Chiesi products, from any possible source, assessment and delivery of high-quality postmarketing safety data in a timely manner, ensuring that it is correct, consistent (including reconciled), compliant and delivered to agencies
Provide oversight of the evaluation of scientific literature at both global and local level to identify case safety reports
Provide oversight of Company sponsored controlled websites/Apps and other social media
Actively engage applicable customers, affiliates and other stakeholders
Participate to interdepartmental meetings inside and outside R&D
Act as the primary source of subject-matter expertise to address any questions from Chiesi staff or from external contacts regarding these activities and processes, being responsible for implementing requirements, trainings, procedures maintenance and vendor oversight
Guarantee data reconciliations with affiliates and contractual partners
Provide appropriate training of relevant internal and vendor staff for these processes, as applicable
Support the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs)
Interact with the Safety Science team for product-specific safety strategy data collection inputs
Supervise and/or review of PV operations-relevant sections of documents pertinent to ODCS with regards to PV topics/involvement (e.g. safety reporting requirements, PV clauses in contracts, reconciliations, vendor selection) including set-up of electronic AE/ADR reporting
Oversee PV operations activities with concerned Contract Research Organizations (CROs), including reconciliation activities; supervising PV agreements with CROs
Ensure data related to each process under the area of competency of PM PV OPS team are properly filled out in the PSMF
Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation
For all GVP audits and inspections, serve as the expert for activities under the role, Pre-work in preparation for the audit/inspection, Direct interviews with auditors/inspectors, as required, and Follow-up on any subsequent actions and CAPAs