GLOBAL MEDICAL SAFETY EXPERT

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 Bogota in the division Established Pharmaceuticals

We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, womens health, cardiometabolic, pain management/central nervous system, and respiratory.

As the Manager Medical Safety- Biosimilars is to provide guidance, direction and expertise for pharmacovigilance activities.

What You’ll Do :

The primary function of the Regional Medical Safety Expert Biosimilars LATAM - Global Medical Safety Expert is to provide guidance, support and expertise for pharmacovigilance activities within one’s responsibility.

This includes :

• Leadership of defined Product Safety Teams
• Responsibility and accountability for the safety of all assigned EPD products with special focus on Biosimilars to ensure compliance
• Liaising with regional I&D functions also outside PV
• Assuming leadership for regional Medical Safety Topics
  
  

Core responsibilities :

• Represents Abbott towards governmental agencies and other competent authorities related to PV topics
• Develops strategic risk management plans for assigned products
• Reviews clinical study protocols, their reports and publications
• Proactively understands region-specific regulatory framework, trends & requirements related to products, clinical studies and global drug development
• Develops and reviews safety information as part of reports submitted to regulatory authorities
• Is accountable for the safety monitoring strategy (including ICSR, aggregate data and literature review) and reference safety information documents throughout a product’s lifecycle, thereby minimizing patient and product risk
• Performs medical assessment during processing of solicited cases
• Participates in Due Diligence activities for regional L&A options
• Supports and guides affiliate safety representatives about
• Safety surveillance incl. Signaling
• Preparation of localized RMPs
• Management of HA deficiency letters
  
  

Position Accountability/Scope :

• Ensures flawless execution of medical safety process in the region with special focus on Biosimilars
• Aligns PV strategy and communicates with external stakeholders in pharmacovigilance activities
• Creates transparency by interacting and communicating with EPD RA, EPD MA, EPD CD and other Functional Areas on a regional and global level
• Works mostly independent but will require some oversight/ guidance
• Support and input in the course of/to assigned projects
  
  

Required Qualifications

• Doctor of Medicine (MD)
  
  

Preferred Qualifications

• Minimum 5 years industry experience in Pharmacovigilance
• Broad and proficient understanding and experience in Pharmacovigilance esp. in Medical Safety
• Experienced professional operating within the international arena, and working across functional areas
• Good negotiating skills, tact and diplomacy. Advanced knowledge of standard business procedures including project management.
• Fluent in English and Portuguese
• Experience with Biosimilars/Biologics

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