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Local Safety Officer - Italy

Employer
Labcorp
Location
Rome, Italy
Salary
Competitive
Start date
15 Nov 2022
Closing date
14 Dec 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Labcorp has an opportunity for an experienced Local Safety Officer in Italy, working dedicated to one client, you will be responsible for regulatory compliance of all pharmacovigilance activities across many projects.

This is a varied opportunity, working across many therapeutic areas for a world leading Sponsor. You will be involved across all areas of pharmacovigilance, you will have the opportunity to liaise internally and externally, across local and global stakeholders. You will also a ssume responsibility for ensuring the quality of assigned Pharmacovigilance projects; contributing to process improvement, training and audit readiness.

Language Skills Required:
  • Fluent: Italian & English.


Responsibilities
  • Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
  • Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
  • Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
  • Performing follow-up for requesting additional information from multiple sources.
  • Verify and ensure translation of safety information, if applicable.
  • Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs).
  • Enable mechanisms to support LSO oversight for case management activities.
  • Ensure timely submission of safety reports to relevant authorities, in collaboration with local medical safety input.
  • Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs).
  • Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes.
  • Assist in addressing periodic client quality reviews.
  • Contribute to discussion forums on Quality errors within assigned project and help identify process improvements.
  • Assist in coordinating respective client or external audits of the assigned projects as requested.
  • Assist in development of Quality Management Plan for assigned project.
  • Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.


Qualifications
  • Health, life or pharmaceutical sciences is preferred but relevant experience will be accepted in lieu of degree.


Experience
  • Recent pharmacovigilance/drug safety experience within Italy, ideally gained from global CRO/Pharma
  • Knowledge of regulatory requirements and applicable EU and FDA guidelines
  • In-depth understanding of case processing and assessment
  • Technical proficiency with Microsoft Office suite of applications


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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