Global Pharmacovigilance Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Abbott A tiempo completo

Position Overview

This role is integral to our division focusing on Established Pharmaceuticals. We are dedicated to expanding access to our reliable medications in rapidly developing markets. Our extensive range of high-quality branded generic medicines spans various therapeutic fields, including gastroenterology, women's health, cardiometabolic conditions, pain management, and respiratory health.

As a Global Medical Safety Expert, your primary responsibility will be to offer strategic guidance and specialized knowledge in pharmacovigilance initiatives.

Key Responsibilities:

  • Act as the representative for Abbott in discussions with regulatory bodies and authorities regarding pharmacovigilance matters.
  • Formulate comprehensive risk management strategies for designated products.
  • Evaluate clinical study designs, their findings, and related publications.
  • Maintain a proactive understanding of the regulatory landscape, including trends and requirements pertinent to products and clinical trials.
  • Provide safety expertise throughout all phases of global drug development.
  • Generate and assess safety data for inclusion in reports submitted to regulatory agencies.
  • Oversee the safety monitoring framework, including individual case safety reports, aggregate data analysis, and literature reviews, to mitigate risks to patients and products.
  • Conduct medical evaluations during the processing of solicited cases.
  • Execute Health Hazard Assessments and Quality Management Evaluations as requested by Quality Assurance.

Accountability and Scope:

  • Collaborate across various functions to support internal stakeholders, particularly the Qualified Person for Pharmacovigilance and affiliate safety representatives.
  • Align pharmacovigilance strategies and engage with external stakeholders in related activities.
  • Foster transparency through communication with Regulatory Affairs, Clinical Development, Medical Affairs, and other functional teams.
  • Operate on a global scale, responsible for all countries with product registrations, primarily within a specific therapeutic area.
  • Work autonomously while occasionally seeking guidance.
  • Provide support and input for assigned projects.

Required Qualifications:

  • Doctor of Medicine (MD) or Doctor of Pharmacy (PhD).

Preferred Qualifications:

  • A minimum of 8-10 years of experience in pharmacovigilance, medical affairs, or clinical development.
  • At least 5 years of experience in pharmacovigilance safety assessments or related fields.
  • Comprehensive understanding and experience in pharmacovigilance within the pharmaceutical industry or academia.
  • Proven track record of operating in an international context and collaborating across functional areas.
  • Strong negotiation skills, with a focus on tact and diplomacy. Advanced knowledge of standard business practices, including project management.

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