Global Medical Safety Expert

hace 3 semanas

Bogotá Cundinamarca, Colombia Abbott Laboratories A tiempo completo

**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

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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