Regional Medical Safety Expert
JOB DESCRIPTION:
Regional Manager 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.
- 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.
The primary function of the Regional Manager Medical Safety is to provide guidance, direction and expertise for pharmacovigilance region-specific PV Medicine activities (process based/local product based).
This includes:
- Close interaction with ASRs/Regional PV Manager to ensure one PV standard for local products
- Liasing with other regional I&D functions
- Assuming ownership for regional selected assigned medical safety topics and processes
- Responsibility and accountability for the safety of assigned local EPD products to ensure compliance)
What You’ll Do :
Proactively understands the region-specific regulatory frameworks, trends & requirements related to products, clinical studies and drug development.
Supports and guides affiliate safety representatives about:
- Safety surveillance including signalling as applicable in their regions.
- Preparation of local annexes to globally prepared RMPs and of RMPs.
- Self-dependent PSUR planning and preparation.
- Management of aggregate reports and the like as applicable.
Proactively understands the region-specific regulatory frameworks, trends & requirements related to products, clinical studies and drug development.
Supports and guides affiliate safety representatives about:
- Safety surveillance including signalling as applicable in their regions.
- Preparation of local annexes to globally prepared RMPs and of RMPs.
- Self-dependent PSUR planning and preparation.
- Management of aggregate reports and the like as applicable.
Supports regional/local RA regarding Safety Labelling (identify originator, label monitoring, etc.), Renewal needs (timing, document requirements) and communication towards governmental agencies and other competent authorities related to Medical Safety topics:
- Plans and performs full medical safety surveillance of assigned local EPD products
- Participates in Due Diligence activities for regional L&A options.
- Participates in digital media or study review boards
- Participates in the identification, direction and implementation of strategic business initiatives within the PV Medicine Group.
Required Qualifications
Doctor of Medicine (MD)
Computer literacy (Windows, MS Office)
Fluency in English language
Fluency in Portuguese language is helpful.
Preferred Qualifications
- Minimum 5 years of industry experience in Pharmacovigilance, with a broad and comprehensive understanding of pharmacovigilance principles, regulations, and practices esp. in the Field of Safety surveillance, Risk-Benefit Evaluation and Aggregate Reporting
- Demonstrated experience operating in an international and cross-functional environment, effectively collaborating with diverse stakeholders across multiple disciplines and geographies.
- Strong negotiation, communication, interpersonal, and influencing skills, combined with a high degree of tact, diplomacy, and professional judgment.
- Excellent training, coaching, and mentoring skills, with demonstrated expertise in advancing organizational capabilities, fostering continuous improvement, and ensuring effective knowledge transfer across diverse teams and stakeholders.
- Advanced knowledge of standard business processes and regulatory procedures, including project management principles, planning, execution, and stakeholder 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.
Connect with us atwww.abbott.com, on Facebook atwww.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.