Medical Safety Expert
hace 5 meses
**Job Title**
**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 location in the Established Pharmaceuticals division.
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 Medical Safety Expert is to provide guidance, direction and expertise for pharmacovigilance activities within one's responsibility.
**What You’ll Do**:
- Performs Health Hazard Assessments and Quality Related Medical Expert Statements
- 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
**Required Qualifications**
- Doctor of Medicine (MD), experienced in Infectiology/Microbiology
- Experience with Biosimilars
**Preferred Qualifications**
- Minimum 3-5 years industry experience in Pharmacovigilance, Medical Affairs of Clinical Development
- Fluent in English
- Broad and proficient understanding and experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalent
- Experienced professional operating within the international arena or working across functional areas
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.
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