Affiliate Safety Representative

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

We are seeking an Affiliate Safety Representative to join our Citywest office in Dublin. In this role, you will lead the coordination and implementation of all pharmacovigilance activities, ensuring that AbbVie's legal and ethical obligations are fulfilled. You will serve as the primary contact for the Affiliate on pharmacovigilance matters, liaising with the National Regulatory Agency and AbbVie’s Pharmacovigilance and Patient Safety (PPS) function. This position provides strategic leadership for managing and supporting the pharmacovigilance team in carrying out their duties. It reports directly to the Affiliate Medical Director, with an additional indirect reporting line to the EU Qualified Person for Pharmacovigilance (QPPV) for all PV-related issues.

Responsibilities:

• Foster effective business relationships across the affiliate to implement patient safety standards.
• Enhance PV systems through continuous improvement and collaboration with PPS experts.
• Support recruitment, training, coaching, and performance management of PV staff.
• Monitor affiliate PV compliance, workload, and resource management.
• Address compliance issues and ensure PV processes for digital media and internet safety data.
• Ensure local SDEAs meet AbbVie procedures and local requirements; manage inventory in PPS PV Agreements Database.
• Maintain compliance with local agreements.
• Serve as key contact for internal PV audits and regulatory inspections.
• Ensure timely audit responses and corrective actions; support vendor audits and corrective plans.
• Collaborate with Affiliate Risk Management Team to review RMPs and implement risk minimization measures.
• Develop and revise Local RMPs with ARMT & Benefit Risk Management Team.
• Monitor medicinal product safety profiles and emergent concerns.
• Communicate safety data changes to PPS Product Safety Team Lead and EU QPPV.
• Establish after-hours reporting and disaster recovery plans for critical PV processes.
• Strengthen relationships with affiliate colleagues and enhance understanding of PV requirements.

• Degree in medical, pharmacy, or life sciences (or equivalent).
• Minimum of 2-5 years in a pharmacovigilance role within the pharmaceutical industry is required; experience managing direct reports is preferred.
• Excellent written and verbal communication and presentation skills.
• Fluency in written and spoken English is essential for communication with Pharmacovigilance and Patient Safety, Area/Regional Medical, and other headquarters functions. Fluency in the local language is required for interactions within the affiliate medical department and with the National Regulatory Agency.
• High focus on customer service.
• Strong commitment to adhering to all relevant regulations and guidelines.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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