Medical Safety and Surveillance Regional Manager

hace 2 semanas

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

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott


At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.


You will have access to:

  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity


This position works out of our Colombia or Mexico location in the Nutrition Division (other location within Latin America with divisional presence could be considered).

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active.

Millions of people around the world count on our leading brands - including Similac, PediaSure, Pedialyte, Ensure, Glucerna and ZonePerfect - to help get the nutrients they need to live their healthiest life.


What You'll Do

  • Closely monitors for and elevates medical/safetyrelated issues in Latin America region in a timely fashion according to global procedures
  • Serves as the Medical Safety representative on crossfunctional teams during escalated product events in regions that may have the potential to impact product safety; drafts and issues medical assessments for potential safety issues in consultation with the global MSS team
  • Responsible for ensuring Latin America affiliates' compliance with all local laws and regulations, as well as Abbott policies and procedures related to medical safety/pharmacovigilance activities; works with affiliate staff to drive development and implementation of new processes and procedures when deemed necessary
  • Provides comprehensive onboarding for new Affiliate Safety Representatives (responsible for conduct of medical safety activities) in countries in the region; ensures no gaps in business continuity during periods of transition to new staff
  • Routinely monitors local affiliates' adherence to global and local procedures; provides ongoing training and ensures corrective actions are implemented when issues/noncompliance is identified; advises management of compliance status and risk
  • Maintains up to date understanding of any local regulations related to medical safety activities, including pharmacovigilance related requirements for Abbott's Nutrition Division products registered as pharmaceuticals/drugs
  • Imparts guidance and support for external inspections/audits that take place at Latin America facilities by local ministries of health and for internal inspections by Corporate auditors; oversees implementation of corrective actions for any findings related to medical safety activities
  • Assists affiliate sites, as needed, in conducting adverse event follow up with external reporters and healthcare professionals
  • Provides Affiliate Safety Representatives guidance and support with customer responses to adverse event reports/medical complaints
  • Works closely with manufacturing sites to ensure appropriate investigation and documentation of the investigation for adverse event reports/medical complaints
  • Maintains visibility to regional adverse event tracking and trending; anticipates and communicates issues (early trends) to the global MSS team which could impact adverse event reporting, analyses, product safety and/or brand reputation
  • Works effectively with multiple functional areas to drive, coordinate, and facilitate improvements in complaint/adverse event handling processes as well as other medical safety related activities
  • Maintains sound understanding of local markets within Latin America region; elevates market sensitivities and business needs as they relate to medical safety activities
  • Participates on crossfunctional Innovation Teams as the MSS representative, and as such, may evaluate and establish nutrient specifications (minimum and maximum Medical Notification Limits) for product development/product optimization. Also may evaluate and establish Medical Impact Limits to facilitate Design Assurance quality decisions for finished product testing.
  • Works closely with the global MSS team to define business objectives in collaboration with leadership; develops goals and process improvements based on the business strategies that align with other functions in the organization

Required Qualifications

  • Master's degree in related health science or equivalent skills, education, or experience.
  • 57 years of related industry experience, preferably pediatric or medical

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