Associate I PSS (Patient Safety)

Helping our clients make their clinical trials a success.

As an Associate I in Patient Safety Services, you assist with the smooth running of the PSS Department to ensure all adverse events are processed to the required standard and submitted to the client and the regulatory agencies. There will be a focus on the translation of a variety of safety related documents collected from clinical trials and/or post marketing settings.

Language Skills Required;

Fluent Greek + additional language skills e.g. Spanish, French or German. Ideally C1 but intermediate level can be accepted.

At Labcorp, we are much more than a typical CRO:

• We were named in Fast Company magazine's list of 2021 Most Innovative Companies for its leadership in scientific innovation in the fight against COVID-19.
• We were also recognized with the 2020 Global CRO Company of the Year Award by Frost & Sullivan for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.

Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

To us this is not a job, but your career.

Duties and Responsibilities:

• Assist in producing queries of safety data for clients as appropriate.
• Assist in the generation and maintenance of the PSS metrics.
• Assist Data Management or clients on reconciliation of safety databases.
• Provide input for monthly status reports.
• Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.
• Build and maintain good PSS relationships across functional units.
• Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
• Demonstrate role-specific Core Competencies on a consistent basis.
• Demonstrate company Values on a consistent basis.
• Assist in the preparation of client meetings and liaise with clients where appropriate.
• Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
• Any other duties as assigned by management.

Experience

Required:

• High degree of accuracy with attention to detail.
• Team player
• Good communication.
• Good written and verbal communication skills.
• Ability to work independently with moderate supervision.

Preferred:

• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

Education/Experience

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Additional relevant work experience will be considered in lieu of formal qualifications.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

#LI-Remote

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 .