Senior Associate Operational Excellence & Compliance

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 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

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634

Fax: (732) 549 5549

http://www.irionline.com

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70