Global Pharmacovigilance

hace 4 semanas

Bogota, 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 location in the Nutritional Division. 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**
- Organizes, manages, and maintains a highly compliant global pharmacovigilance system for Abbott Nutrition
- Maintains awareness and ensures compliance with established and updated local and global pharmacovigilance processes as well as local and global regulations and guidelines for pharmacovigilance
- Develops and implements training programs for individuals involved in pharmacovigilance activities
- Monitors pharmacovigilance system performance; tracks compliance metrics and reports to global MSS Leadership Team
- Ensures global/local pharmacovigilance audit readiness; Supports pharmacovigilance audits/inspections and leads activities related to corrective and preventative actions for any audit findings
- Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as drugs, such as signal detection, evaluation, and prioritization
- Provides oversight of entry of data into the safety database; ensures data is accurate and complete
- Assists local staff with drafting and implementation of Safety Data Exchange Agreements
- Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures
- Assists in the preparation, review, and submission of aggregate safety reports
- Accountable for strategic pharmacovigilance activities for the division

**Required Qualifications**
- Bachelor’s degree in related health science or equivalent skills, education: Master’s degree preferred
- 5-7 years of experience and proficiency in drug safety/pharmacovigilance and in the development and implementation of compliance processes in a pharmacovigilance setting
- Solid understanding and working knowledge of pharmacovigilance regulatory requirements
- Strong medical knowledge and understanding to support safety-related activities; background/experience with nutrition/nutritional products is a plus
- Fluency in spoken/written English; Fluency in spoken/written Spanish is a plus.
- Computer proficient (Windows, Word, Excel); experience working in adverse event databases
- Excellent communication and interpersonal skills, both written and spoken.
- Strong organizational skills with a proven ability to prioritize and work on multiple tasks and projects
- Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity
- 20% to 25 % traveling is required

**Preferred Qualifications**
- Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable

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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