Affiliate Safety Representative

The Affiliate Safety Representative (ASR) is responsible for ensuring that all aspects of Pharmacovigilance (PV) within the Affiliate meet AbbVies statutory and ethical standards and comply with local and regional PV regulations for the product portfolio. The ASR acts as the Affiliates Lead for PV matters with the National Regulatory Agency and AbbVie Global Patient Safety (GPS) PSEQ function.

Key Responsibilities:

• Oversight of the local Pharmacovigilance System to ensure compliance with AbbVie Global procedures and relevant regulations.
• Collaborate with Regional PV Teams and partners to monitor PV activities and performance.
• Partner to maintain Quality Management Systems and oversee PV training compliance.
• Ensure robust systems for Adverse Event and Periodic Safety Reporting across spontaneous solicited and clinical study sources.
• Serve as Affiliate lead during Regulatory Authority PV inspections and internal audits.
• Advise cross-functional partners on PV requirements safety information handling and PV agreements.
• Support PV training and educational initiatives for local teams and partners.
• Monitor legislation intelligence and assess impacts on PV systems.
• Lead local risk management activities including Risk Management Plans and implementation of risk minimisation measures.
• Maintain awareness of safety profiles and emerging concerns for AbbVie products within the jurisdiction.
• Drive PV advocacy and participate in internal and external collaborations with stakeholders and agencies.
• Ensure preparedness for after-hours availability and business continuity through PV Disaster Recovery Plans.

Qualifications :

• BSc MPharm or PhD in a scientific discipline (preferred)
• Minimum two years experience in the pharmaceutical industry in a pharmacovigilance role
• Excellent written and verbal communication and presentation skills
• Fluency in English
• High customer orientation and commitment to compliance and scientific integrity
• Strong scientific acumen judgment planning and organisational skills; demonstrated sense of urgency

Additional Information :

Stakeholders:

• Internal: Medical Regulatory Affairs Clinical Quality Assurance Customer Service Marketing Sales Operations Patient Experience Customer Excellence General Manager
• External: National Regulatory Agency GPS (Regional PV Team QPPV Office Risk Management Teams) healthcare practitioners consumers and patients

Ready to shape the future of patient safety at AbbVie Apply now and bring your pharmacovigilance expertise to our passionate teammake an impact where it truly matters!

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time