GRAPS Safety Operations, Clinical Trials Manager

Chiesi Group; Parma; Ibrido; EUR 46.000 - 58.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Remote work options

Descrizione del lavoro

Chiesi Group, headquartered in Parma, is seeking a Pharmacovigilance professional to lead PV OPS activities for interventional trials in a diverse, international setting. You will ensure PV requirements are embedded in processes, train staff, and collaborate with CROs and affiliates to deliver high-quality safety data.

The role requires a Master’s in science or related field, 4+ years in R&D with PV/Clinical Research experience, and strong communication and analytical skills.

Competenze

• 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 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

Mansioni

• Carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials (CT) sponsored 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
• 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

Descrizione del lavoro

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

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

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

Compensation range

The budgeted salary range approved for this role is between €46.000 and €57.500. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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.