Regional Medical Safety Expert (Pharmacovigilance)

About the role

Abbott's Established Pharmaceuticals division is hiring a Regional Medical Safety Expert (Regional Manager Medical Safety) based in Bogota. The role provides guidance, direction and expertise for region-specific pharmacovigilance medicine activities, covering process-based and local product-based work. It involves close interaction with the ASRs and the Regional PV Manager to ensure one PV standard for local products, liaison with other regional I&D functions, and ownership of assigned medical safety topics and processes.

Key responsibilities

• Support and guide affiliate safety representatives on safety surveillance including signalling, preparation of local annexes to globally prepared RMPs and RMPs, and self-dependent PSUR planning and preparation
• Manage aggregate reports and similar documents as applicable
• Support regional and local RA on safety labelling (identifying originator, label monitoring) and renewal needs, and communicate with governmental agencies and competent authorities on medical safety topics
• Plan and perform full medical safety surveillance of assigned local EPD products
• Take part in due diligence activities for regional L&A options, digital media or study review boards, and in the identification and implementation of strategic business initiatives within the PV Medicine Group

Required profile

• Doctor of Medicine (MD)
• Fluency in English; fluency in Portuguese is helpful
• Preferred: minimum 5 years of industry experience in pharmacovigilance, with strong knowledge of safety surveillance, risk-benefit evaluation and aggregate reporting
• Experience in an international, cross-functional environment and strong negotiation, communication and mentoring skills

Required skills

• Computer literacy (Windows, MS Office)
• Advanced knowledge of standard business processes and regulatory procedures, including project management principles