JOB DESCRIPTION:

Job Title

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, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the Global Medical Safety Expert is to provide guidance, direction and expertise for pharmacovigilance activities.

What You’ll Do :

• Represents Abbott towards governmental agencies and other competent authorities related to Pharmacovigilance topics
• Develops strategic risk management plans for assigned products
• Reviews clinical study protocols, their reports and publications
• Proactively understands regulatory framework, trends & requirements related to products and clinical studies
• Provides safety expertise throughout all stages of 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
• Performs HHAs and QMES upon request by QA

Position Accountability/Scope:

• Interacts across functions to support internal stakeholders, in particular QPPV and the affiliate safety representatives
• Aligns PV strategy and communicates with external stakeholders in pharmacovigilance activities
• Creates transparency by interacting and communicating with EPD RA, EPD Clinical Development and Medical Affairs, and other Functional Areas
• Global scope: is responsible for all countries with registrations for assigned products/APIs, mainly but not exclusively within one therapeutic area
• Works mostly independently, but will require some oversight/guidance
• Support and Input in the course of/to assigned projects

Required Qualifications

• Doctor of Medicine (MD) or Pharmacist (PhD)

Preferred Qualifications

• Minimum 8-10 years industry experience in Pharmacovigilance, Medical Affairs of Clinical Development
• At least 5 years experience in Pharmacovigilance Safety Assessments/PV Medicine
• Broad and proficient understanding and experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalent
• 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

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Product Development

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Colombia > Bogota : Calle108 No 51-45

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable