Job Description

Project Manager, Patient Safety Solutions Home-based in Canada The Project Manager, Patient Safety Solutions (PSS) manages \xe2\x80\x98Client\xe2\x80\x99 or \xe2\x80\x98Project\xe2\x80\x99 specific PSS 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) for specified projects. Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The 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. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Main Responsibilities:

• Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
• Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
• Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
• Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects.
• Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.
• Complete triage, distribution checklist and quality review of all ESRs for assigned projects.
• Provide oversight and management of EudraVigilance activities for assigned projects.

Qualifications: Minimum Level of education required (or experience level which may be substituted for level of education):

• Non-degree + 6-7 yrs safety experience*
• Associate degree + 5-6 yrs safety experience*
• Associate degree RN + 5-6 yrs safety experience*
• BS/BA + 4-5 yrs safety experience*
• MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)
• PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)

• Compliance with client and global regulatory requirements

• Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines

• Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation

• Good knowledge of ICH guidelines

• Good knowledge of medical and drug terminology

• Good verbal, written and presentation skills

• Leadership capabilities

• Anticipate/identify problems and takes appropriate action to correct.

• Knowledge of Medical Device Reporting desirable

• Knowledge of aggregate reporting

• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance..

• Financially intuitive

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.