Pharmacovigilance Professional

We seek an experienced Pharmacovigilance Expert to join our client's Pharmacovigilance Department on a permanent full-time contract.

Key Responsibilities:

• Maintain adherence to the Quality System and Pharmacovigilance Quality System.
• Process case reports in a timely manner, maintaining global safety databases efficiently.
• Screen literature for Safety information and Identify potential signals.
• Conduct periodic case reconciliations with clients and business partners.
• Draft and finalize PVAs and SDEAs with clients and business partners.
• Support inspection readiness activities.
• Investigate non-conformances and manage CAPA initiatives.
• Manage Pharmacovigilance compliance metrics.
• Develop quality system initiatives to enforce quality culture.
• Support audits and inspections.
• Prepare signal detection reports and other regulatory documents.

Requirements:

• Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related field.
• Minimum 2 years of experience in pharmacovigilance and quality management.
• Commercial awareness and project management skills.
• Understanding of EU and UK pharmacovigilance legislation.
• Meticulous record-keeping and strong attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

This role is located in Waterford, Ireland. For more details and application instructions, please visit the company website.