Job Description

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries. Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. Did you know? In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023. We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com The Drug Safety Associate II is a home based position located anywhere in Canada.
The Associate II Patient Safety Services (PSS) is responsible for assisting 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 (if required) within the agreed upon timelines. This post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Main Responsibilities:

• Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
• Intake and Triage
• 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.
• 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.

Qualifications:

• BS/BA + min of 1 year of Post Marketing Drug Safety experience

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.