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.