Jobs in Cambridge, MA

About the role

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. The Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection, Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives. Where relevant, when partners (e.g. Quintiles Strategic Partnership) have additional safety related responsibilities, the manager ensures proper coordination between the partner and the SABR Subject Matter Expert/function lead

What you'll bring

• Bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences required
• 4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent
• Experience interacting with clinical third parties (e.g.
• Knowledgeable in Pharmacovigilance and GCP legislation required
• Other Posting Information – Information to be included in posting (as required)
• Excellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
• Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize
• Ability for individual decision-making required
• Must demonstrate initiative to identify and communicate issues within department and across departments
• Communicates study-specific requirements for AE intake
• Identifies and implements corrective and preventative actions (CAPAs) resulting from non-compliances