Senior Associate Pharmacovigilance

Our direct Client is looking to hire Senior Associate Pharmacovigilance Position

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 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.

Archana Melwani

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 – 2007-2014 (8th Year)

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

Tel: 732-549-2030 x130

Direct: 732-429-1853

Fax: 732-549-5549