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.