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 Senior Project Lead, Patient Safety Services (PSS) is a home based position located anywhere in Canada.
The Senior Project Lead assists with the overall Clinical Safety and/or departmental operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Ensure that for assigned projects, expeditable adverse events reporting is completed to the required standard and submitted to client and regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Main Responsibilities:

• Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
• Ensure compliant safety reporting in accordance with international reporting regulations, SOPs and safety processing guidelines, for assigned projects.
• Maintain a strong understanding of Labcorp\xe2\x80\x99s safety database conventions or client-specific database conventions, as appropriate.
• Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports,
• Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports.
• Actively participate in and demonstrate leadership on projects which enhance team and/or division performance. This will include acting as safety lead for projects at global or regional level, ensuring communication and process harmonization.
• Work with internal or external partners for reconciliation of safety databases, if appropriate.
• Ensure compliant safety reporting in accordance with US and international regulatory reporting requirements, SOPs and safety processing guidelines set forth by departmental management team and the client.
• Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.

Qualifications: \xef\x82\xa8 Non-degree + 5 years Safety experience* \xef\x82\xa8 Associate degree + 3-4 years Safety experience* \xef\x82\xa8 BS/BA + 3 years Safety experience* \xef\x82\xa8 MS/MA + 2-3 years Safety experience* or 2 years relevant experience** \xef\x82\xa8 PharmD + 1 year Safety experience* or 2 years relevant experience** For PharmD, a one-year residency of fellowship can be considered relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

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

**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, Project Management or Quality Assurance. 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.