Descrizione dell'offerta
This is what you will do
Carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials 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 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 (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 to 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 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 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.
Benefits
Pension
Private medical insurance
Wellbeing programme
Flexible benefits programme
And more (including comprehensive healthcare programs, work‑life balance initiatives, robust relocation support, flexible working arrangements, remote work options and tax assistance services for foreign colleagues).
Equal Opportunity Statement 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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Carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials 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 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 (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 to 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 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 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.
Benefits
Pension
Private medical insurance
Wellbeing programme
Flexible benefits programme
And more (including comprehensive healthcare programs, work‑life balance initiatives, robust relocation support, flexible working arrangements, remote work options and tax assistance services for foreign colleagues).
Equal Opportunity Statement 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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