Regional Medical Safety Expert

About the role

Abbott's Established Pharmaceuticals division is hiring a Regional Medical Safety Expert (also called Regional Manager Medical Safety) in Bogota, Colombia. The role provides guidance, direction and expertise for region-specific pharmacovigilance medicine activities, covering process-based and local product-based work. It sits in the Product Development job family.

Key responsibilities

• Work closely with Affiliate Safety Representatives and the Regional PV Manager so that all local products follow one PV standard.
• Take ownership of assigned regional medical safety topics and processes, and be accountable for the safety of assigned local EPD products and their compliance.
• Guide safety representatives on safety surveillance and signalling, preparation of local annexes to global RMPs and of RMPs, self-dependent PSUR planning, and management of aggregate reports.
• Support regional and local regulatory affairs on safety labelling, renewal needs and communication with governmental agencies and competent authorities on medical safety topics.
• Plan and perform full medical safety surveillance of assigned local products, and take part in due diligence for regional licensing options, digital media or study review boards, and 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.
• Preferred: experience in an international, cross-functional environment and strong negotiation, communication and mentoring skills.

Required skills

• Computer literacy (Windows, MS Office)
• Knowledge of regional regulatory frameworks and pharmacovigilance regulations