GRAPS Safety Operations, Clinical Trials Manager

About us

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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).
Who we are looking for

This is what you will do

To carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials (CT) sponsored either by GCD or GRD functions by maintaining up-to-date processes for safety-related aspects of interventional clinical trials, to meet current and evolving PV legislation
You will be responsible for

Support the GRAPS Safety Operations CT Head in ensuring that all current PV requirements for interventional clinical trials are effectively incorporated into Chiesi processes and documented in procedures
Ensure strategic collection, assessment and delivery of high-quality clinical trial safety data in a timely manner, ensuring that it is correct, consistent, compliant and delivered to agencies
Actively engage CT customers, affiliates and other stakeholders
Participate in interdepartmental meetings inside and outside R&D
Act as owner (i.e. subject matter expert) for specific processes under the area of competency of CT PV OPS Unit, responsible for implementing requirements, training, procedure maintenance, vendor oversight
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 clinical trials with regards to PV topics/involvement
Oversee PV operations activities with concerned Contract Research Organizations (CROs)
Ensure data related to each process under the area of competency of CT 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
Manage PV OPS activities throughout Post-Integration phases, for R&D assets
For all GVP and GCP audits and inspections, serve as the expert for activities under the role
Actively participate in process improvement activities within the GRAPS department
Maintain compliance with relevant regulations, policies and procedures
You will need to have

Master degree in science, medicine, biology, pharmacy or related fields
Minimum 4 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance or Clinical Research.
Willingness to operate in a diverse, international environment.
Excellent communication and interpersonal skills
Ability to work with initiative and autonomy, demonstrating determination in achieving goals and tackling daily challenges
Problem solving and decision making skills
Planning and analytical skills
Fluent English
We would prefer for you to have

Awareness of the principles of global pharmacovigilance requirements
Awareness of GCP requirements
Knowledge of MedDRA coding dictionary and its principles
Location