Local Safety Officer

6 giorni fa

Roma, Italia Labcorp A tempo pieno

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 assume 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

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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