Specialist, Pharmacovigilance Auditor

Job Description

Are you looking for an exciting opportunity with a growing pharmaceutical

manufacturer? If so, then this is the opportunity for you!

Responsible to support PV Quality System audits our company's Animal Health own sites/entities, CROs and system audits. Support to monitor all aspects of the operational business comply with GXP legal and Regulatory Requirements and our company's Animal Health Policies and Procedures.

Job description

• Responsible to support and participated in planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with CRO’s, laboratories, contactors and external business partners

• Support PV audits as required.

• Review and Approve Corrective and Preventive Actions (CAPA)s which are necessary due to audit findings.

• Assure maintenance of audit data in a related data system (incl. reports and follow-up of audits)

• Co-ordinate the planning of PV Audit training sessions, and compilation of PV Audit Risk Assessments (e.g., for Supplier Qualification)

• Support our company Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits, “Mock Inspections”, training and other support activities.

• Support the conduct effective “Due Diligence” activities of potential in-licensed products, acquisitions and partners as required.

• Identify and report critical and major quality and compliance risks and gaps during audit activities.

• Ensure effective follow-up audits of sites with significant quality and compliance issues.

• Support the conduct effective “For Cause” audits to investigate frequent field alerts, recalls, rejects and complaints.

• Support in informing Senior Management of emerging regulatory and PV trends to help avoid compliance risks.

• Provide effective support during regulatory inspections as requested by QA.

• Willing to travel extensively and on short-term off-site assignments for remediation projects based on business needs.

Qualifications

 Requirements: 

• A bachelor’s degree in a Scientific Discipline/Life Sciences or related discipline. A Master’s degree in a relevant discipline or higher degree preferred.

• A minimum of two (2) years of pharmaceutical industry experience in a compliance-related area (e.g. PV, QA, Auditing, work in GLP, GCP, GMP environments), with a minimum of one (1) year experience in Quality Assurance/Auditing/Pharmacovigilance.

• Excellent interpersonal skills, i.e., ability to build constructive relationships, positive & constructive attitude, desire, and ability to work in interdisciplinary teams.

• Very good organizational, communication, and negotiating skills.

• Very good written and verbal communication skills in English.

• Ability to facilitate and/or lead a variety of meeting formats.

• Ability to perform in a multi-task and multi-cultural environment.

• Good computer skills.

• Preferred Experience and Skills: Working knowledge of global pharmacovigilance procedures …