GRAPS Safety Operations, Clinical Trials Manager

Questa posizione è in Chiesi Group

Riassunto dell'opportunità da parte della Joinrs AI: Chiesi Group cerca un Clinical Trials Manager con laurea magistrale in scienze, medicina, biologia, farmacia o affini per gestire attività di farmacovigilanza in studi clinici interventistici. Il ruolo prevede responsabilità nella raccolta e valutazione della sicurezza dei dati clinici, collaborazione con team multidisciplinari e supervisione di procedure operative. L’offerta include contratto a tempo indeterminato, salario minimo di €46.000, bonus annuale, lavoro ibrido da Parma e un pacchetto completo di benefit tra cui assicurazione privata e programmi di benessere.

Il processo di selezione sarà interamente gestito da Chiesi Group.

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GRAPS Safety Operations, Clinical Trials Manager

Date: 1 Jul 2026

Department: Global Regulatory Affairs & Patient Safety

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, 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.

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

• Carry out pharmacovigilance (PV) operations activities in interventional clinical trials (CT) sponsored by GCD or GRD functions, maintaining up-to-date processes for safety-related aspects in compliance with evolving legislation.

You will be responsible for

• Support the GRAPS Safety Operations CT Head in ensuring incorporation of PV requirements in procedures
• Ensure strategic collection, assessment and delivery of high-quality and compliant clinical trial safety data to agencies
• Engage CT customers, affiliates and other stakeholders actively
• Participate in interdepartmental meetings inside and outside R&D
• Act as subject matter expert for specific processes, including training, procedure maintenance, and vendor oversight
• Provide training for internal and vendor staff as applicable
• Support Case Management team for activities involving Pharmacovigilance Service Providers
• Interface with Safety Science team for product-specific safety strategy inputs
• Supervise and review PV operations sections of clinical trial documentation
• Oversee PV operations with Contract Research Organizations (CROs)
• Manage relevant data in the Pharmacovigilance System Master File (PSMF)
• Handle deviations, investigations and CAPA plans
• Manage PV OPS activities during Post-Integration phases for R&D assets
• Serve as expert for GVP and GCP audits and inspections regarding role activities
• Participate actively in process improvement within GRAPS
• Maintain compliance with regulations, policies and procedures

You will need to have

• Master degree in science, medicine, biology, pharmacy or related fields
• Minimum 4 years experience in R&D within Pharmaceutical and/or Biotechnology industry
• At least 3 years experience in Pharmacovigilance or Clinical Research
• Willingness to operate in diverse, international environments
• Excellent communication and interpersonal skills
• Ability to work with initiative and autonomy, showing determination
• Problem solving and decision making skills
• Planning and analytical abilities
• Fluent English

We would prefer for you to have

• Awareness of global pharmacovigilance requirements
• Knowledge of GCP requirements
• Knowledge of MedDRA coding dictionary and principles

Location

The position is based at our headquarters in Parma and offers a flexible hybrid working arrangement.

Compensation range

The minimum salary for this role is €46.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

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