Senior Associate Operational Excellence & Compliance

Integrated Resources • Cambridge, Massachusetts, United States • 1w ago

Company Description

A Few Words About Us
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.

Job Description

Principal Duties

• Collaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP)

• Coordinates PV-related aspects of inspection readiness activities

• Assists and other departments in addressing audit findings and development of Corrective and Preventative Actions (CAPAs)

• Participates in development and reporting of compliance metrics related to GVP activities

• Conducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities

• Assist in hosting of regulatory inspections related to PV

• Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate

• Responsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)

• Monitors commitments from internal audit and regulatory inspection findings

• Performs late case investigations and writes delayed case reports

Qualifications

Qualifications and Experience:

• In depth understanding of clinical research and pharmacovigilance operations and regulations-in particular an excellent knowledge of ICH GCP, GVP as well as FDA, EU and ROW regulations

• 5 + years of experience in clinical research and/or pharmacovigilance, including compliance

• Team player with excellent interpersonal skills

• Strong attention to detail and excellent communication skills, both written and oral.

• Excellent knowledge of SOPs and auditing/compliance background preferred

Education:

• Bachelor's Degree required.

• Master's Degree preferred.

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc