Italy Registered Nursing Job Opportunities
The first step in applying to the Italian Ministry of Health is to have your professional qualification recognized. Once you have your qualification ready, or equivalent by decree, you must contact the competent provincial OPI and apply for registration.
Italy is a country of outstanding natural beauty, historical wonders, and a varied culture steeped in art, fashion, food, and music - you'll require specialist skills and a full grasp of the language if you have aspirations of working in Italy as a nurse.
Sr QPPV Office Specialist - Medical Device expertise.
Description;
Senior Qualified Person for Pharmacovigilance (QPPV) Office Specialist with Medical Device expertise needed in Italy.
Come discover what their 25,000+ employees already know: work here matters everywhere. They're a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts worldwide and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help them deliver results for a rewarding reason – They improve patients’ lives worldwide. Because to them, a patient isn’t just a number; they’re their family, friends, and neighbors.
Why Syneos Health in Italy
SyneosHealthLife means They’re committed to their total Self-culture – where everyone can authentically be themselves. Their total self-culture unites them globally, and we know every person’s unique contributions make a difference.
They believe their success is a direct result of the people driving it – you! They value your dedication to caring for their customers and patients, so they want to focus on taking care of you. That’s why they offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
They are continuously building the company they all want to work for and their customers want to work with.
Why? Because when they bring together diversity of thoughts, backgrounds, cultures, and perspectives – they’re able to create a place where everyone feels like they belong.
Job Responsibilities in Italy
Assist the assigned QPPV team with various tasks, meetings, and deliverables about specific allocated projects.
Provide input to proposals and project budgets.
Participate in the generation and maintenance of quality documents as needed (Policies, SOPs, Charters, Agreements, etc.) in Syneos or about allocated projects.
Mentor and train global and local PV and non-PV staff to ensure knowledge sharing about PV processes and required quality, legislation, and compliance.
Liaise with local Safety officers in allocated projects as needed and, where required, assume vendor management activities for any outsourced post-marketing services included via Syneos Health in global assigned projects.
Draft, analyze and help develop safety and pharmacovigilance documents as needed to ensure overall project compliance.
Maintains continuous knowledge and expertise in GVP requirements for pre- and post-marketing pharmacovigilance to ensure sufficient update-to-date advisory skills.
Support and guide relevant client members and other project team members to deliver relevant objectives about the SDEA, including but not limited to safety training, inspection readiness and PV system set-up, and PSMF deliverables.
Performs other work-related duties as assigned.
Assigned as primarily responsible for delivering the Client PSMF.
Overall responsible for supporting and coordinating the PSMF, including all stages in the building, registration, and maintenance of the assigned client’s Pharmacovigilance System Master File(s).
Draft and finalize all documents associated with the PSMF process and facilitate all review processes and approvals.
Other Duties
Maintain PSMF Repository for allocated projects.
Assist the QPPV Office team to ensure delivery and updates to the client’s PSMF. Ad hoc and upon urgent request.
Act as a quality and compliance specialist in the post-approval PV area
Interact directly with clients to collate information for PSMF.
Implement the PSMF outlined KPIs in client’s PV systems.
Perform Maintenance of the PV system in Syneos Health and provide attention to detail with allocated client’s quality documents and processes related to the PV Quality system.
Support in enhancing the PV Quality system for allocated projects as needed.
Draft, update, and author PV Corrective and Preventative action (CAPA) plan to ensure correct reflection of open findings and deviations in the PSMF and work on associated changes or updates to the Syneos Health or client procedures, whichever apply.
Can act as lead operational PV CAPA support for clients' identified deviations or findings to enhance their PV Quality System.
Lead or support gap analysis of client pharmacovigilance systems.
Assigned as primary responsible SDEA Specialist to specific projects and is responsible for ensuring that the client SDEAs are in place and the components included in the SDEAs are updated and prepared according to plan, procedures, and legislation to ensure compliance.
Complete contractual review and manage Client/customer third Party agreements, or draft new or updated contracts concerning pharmacovigilance and the exchange of safety data.
Arrange meetings to coordinate and finalize the client’s third Party Agreements to ensure finalization and implementation.
Minor Functions
Maintain contractual overview for the assigned clients when relevant to SDEA oversight.
Participate in internal improvements of the Syneos SDEA processes and SDEA templates covering the post-marketing PV system.
Interact directly with clients, and their third parties, including their respective operational teams and legal stakeholders, to collate, update or clarify information for the contracts & agreements, including SDEAs, as needed.
Implement the finalized SDEA and train all involved parties responsible for safety activities and timelines outlined in the SDEA.
Act as a contact point for business partners, other departments, third-party provider(s), authorities and other partners regarding SDEAs for allocated projects.
Draft, update, and author PV corrective and preventative action (CAPA) plans when related to the SDEA area or other area as defined in the SDEA template.
Act as SDEA SME and go-to point of contact for allocated projects.
Minimal travel may be required (up to 25%).
Qualification for this Job in Italy
What they’re looking for
BA/BSc. in life sciences, Registered Nurse (RN), pharmacist or equivalent combination of education and experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
Exposure to and knowledge of QPPV-related activities
Very structured and detail-oriented with an excellent ability to keep an overview of complex projects.
Excellent communication skills including written and verbal communication.
Excellent understanding of post-marketing safety requirements, ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and the internet. Basic MS Project skills are preferred.
Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
Ability to perform several tasks simultaneously to meet deadlines preferred.
Get to know Syneos Health.
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, more innovative, faster way to get medicines into the hands of patients who need them most. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities, as listed in this job description, are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and education will also be considered, so the qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, regarding the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Sr QPPV Office Specialist - Medical Device expertise.
Description You Need;
Senior Qualified Person for Pharmacovigilance (QPPV) Office Specialist with Medical Device expertise needed
Come discover what their 25,000+ employees already know: work here matters everywhere. They're a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts worldwide and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help them deliver results for a rewarding reason – They improve patients’ lives worldwide. Because to them, a patient isn’t just a number; they’re their family, friends, and neighbors.
Why Syneos Health
Syneos Health Life means They’re committed to their total Self-culture – where everyone can authentically be themselves. Their total self-culture unites them globally, and we know every person’s unique contributions make a difference.
They believe their success is a direct result of the people driving it – you! They value your dedication to caring for their customers and patients, so they want to focus on taking care of you.
That’s why they offer a comprehensive benefits program encompassing your total health - physical, mental, and financial.
They are continuously building the company they all want to work for, and their customers want to work with. Why? Because when they bring together a diversity of thoughts, backgrounds, cultures, and perspectives – they’re able to create a place where everyone feels like they belong.
Job Responsibilities
- Assist the assigned QPPV team in relation to various tasks, meetings and deliverables in relation to specific allocated projects.
- Provide input to proposals and project budgets.
- Participate in the generation and maintenance of quality documents as needed (Policies, SOPs, Charters, Agreements, etc.) in Syneos or about allocated projects.
- Mentor and train global and local PV and non-PV staff to ensure knowledge sharing about PV processes and required quality, legislation, and compliance.
- Liaise with local Safety officers in allocated projects as needed and, where required, assume vendor management activities for any outsourced post-marketing services included via Syneos Health in global assigned projects.
- Draft, analyze and help develop safety and pharmacovigilance documents as needed to ensure overall project compliance.
- Maintains continuous knowledge and expertise in GVP requirements for pre- and post-marketing pharmacovigilance to ensure sufficient update-to-date advisory skills.
- Support and guide relevant client members and other project team members to deliver relevant objectives about the SDEA, including but not limited to safety training, inspection readiness and PV system set-up, and PSMF deliverables.
Performs other work-related duties as assigned.
- Assigned as primary responsibility for delivering the Client PSMF.
- Overall responsible for supporting and coordinating the PSMF, including all stages in the building, registration, and maintenance of the assigned client’s Pharmacovigilance System Master File(s).
- Draft and finalize all documents associated with the PSMF process and facilitate all review processes and approvals.
- Maintain PSMF Repository for allocated projects.
- Assist the QPPV Office team to ensure delivery and updates to the client’s PSMF. Ad hoc and upon urgent request.
- Act as a quality and compliance specialist in the post-approval PV area
Secondary Responsibilities
- Interact directly with clients to collate information for PSMF.
- Implement the PSMF outlined KPIs in the client’s PV systems.
- Perform Maintenance of the PV system in Syneos Health and provide attention to detail with allocated client’s quality documents and processes related to the PV Quality system.
- Support in enhancing the PV Quality system for allocated projects as needed.
Draft, update, and author PV Corrective and Preventative action (CAPA) plan to ensure correct reflection of open findings and deviations in the PSMF and work on associated changes or updates to the Syneos Health or client procedures, whichever apply. - Can act as lead operational PV CAPA support for clients' identified deviations or findings to enhance their PV Quality System.
- Lead or support gap analysis of client pharmacovigilance systems.
- Assigned as primary responsible SDEA Specialist to specific projects. And is responsible for ensuring that the client SDEAs are in place and the components included in the SDEAs are updated and prepared according to plan, procedures, and legislation to ensure compliance.
- Complete contractual review and manage Client/customer third Party agreements, or draft new or updated contracts concerning pharmacovigilance and the exchange of safety data.
- Arrange meetings to overall coordinate, negotiate and finalize the client’s third Party
- Agreements to ensure finalization and implementation.
Other Responsibilities
Maintain contractual overview for the assigned clients when relevant to SDEA oversight.
Participate in internal improvements of the Syneos SDEA processes and SDEA templates covering the post-marketing PV system.
Interact directly with clients, and their third parties, including their respective operational teams and legal stakeholders, to collate, update or clarify information for the contracts & agreements, including SDEAs, as needed.
Implement the finalized SDEA and train all involved parties responsible for safety activities and timelines outlined in the SDEA.
Act as a contact point for business partners, other departments, third-party provider(s), authorities, and other partners regarding SDEAs for allocated projects.
Draft, update, and author PV corrective and preventative action (CAPA) plans related to the SDEA area or other areas defined in the SDEA template.
Act as SDEA SME and go-to point of contact for allocated projects.
Minimal travel may be required (up to 25%).
Qualifications
What they’re looking for
- BA/BSc. in life sciences, Registered Nurse (RN). pharmacist or equivalent combination of education. and experience or an equivalent combination of education and experience. that gives the individual the necessary knowledge, skills, and abilities to perform the job.
- Exposure to and knowledge of QPPV-related activities
Very structured and detail-oriented with an excellent ability to keep an overview of complex projects. - Excellent communication skills including written and verbal communication.
- Excellent understanding of post-marketing safety requirements, ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook),
- TeamShare (or other management/shared content/workspace), and the internet. Basic MS Project skills is also welcome
- Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
- Ability to perform several tasks simultaneously to meet deadlines preferred.
Get to know Syneos Health.
They are the only full-service biopharmaceutical solutions company in the world. That means they bring together the best clinical and commercial minds to create a better, more innovative, faster way to get medicines into the hands of patients who need them most.
Additional Information
Tasks, duties, and responsibilities, as listed in this job description, are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and education will also be considered so the qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained here is to comply with all obligations fully. That is imposed by the legislation of each country in which it operates. Including the implementation of the EU Equality Directive. in relation to the recruitment and employment of its employees.
The Company complies with the Americans Disabilities Act. Including the provision of reasonable accommodations. When appropriate, to assist employees or applicants to perform the essential functions of the job.
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Conclusion
Italy Registered Nursing Job Opportunities. This is an article from "mouthyTech," which creates awareness of the available nursing jobs in Italy.
However, the article focuses on two central registered nursing job vacancies in Italy. The qualification for the jobs, the major responsibilities of the position, the minor duties for the job position, etc
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