Global Medical Safety Expert – Biosimilars

JOB DESCRIPTION:

Job Title

GLOBAL MEDICAL SAFETY EXPERT BIOSIMILARS

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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 worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.

As the Global Medical Safety Expert Biosimilars provide expert leadership direction and scientific guidance for pharmacovigilance activities within assigned area of responsibility.

What Youll Do :

• Serves as a Global Point of Contact for Biosimilars
• Represents Abbott in interactions with governmental agencies and other competent authorities on Pharmacovigilance matters
• Develops strategic risk management plans for assigned products; ensures appropriate content communication affiliate readiness and Tracking of required additional riskminimization measures.
• Reviews clinical study protocols safety reviews plans clinical study reports and scientific publications to ensure appropriate considerations of safety matters compliance and patient safety throughout all stages of clinical development
• Proactively understands regulatory framework trends & requirements related to products and clinical studies
• Provides safety expertise throughout all stages of global drug development and product Lifecycle management.
• Develops and reviews safety information needed for regulatory submissions.
• Develops and leads the safety monitoring strategy including (ICSR aggregate data signal management literature surveillance) and ensures safety sections of reference safety information documents are adequately reflecting the safety profile throughout a products lifecycle thereby minimizing patient and product risk.
• Performs Medical assessment during processing of solicited cases
• Assesses medical impact of product quality complaints/issues.
• Leadership of Product Safety teams
• Responsibility and accountability for the safety of all assigned EPD products esp. Biosimilars to ensure compliance.

Position Accountability/Scope:

• Interacts across functions within global Pharmacovigilance to support internal stakeholders in particular QPPV and the affiliate safety representatives for any PV Medicine related topic
• Is accountable for and leads the execution of the safety monitoring strategy
• Creates transparency and alignment of safety strategies/initiatives through effective communication with EPD Quality Unit EPD Regulatory Affairs EPD Clinical Development EPD Medical Affairs and other key functional areas
• Drives effective engagement with license partners by establishing robust communication pathways providing strategic input to PVrelated negotiations and ensuring consistency of PVrelevant documentation with global and local compliance standards.
• Drives the creation improvement and global alignment of PV governance documents (SOPs WIs) to ensure standardized and compliant crossfunctional and external collaboration
• Operates with a high level of independence but will require some oversight/guidance
• Provide expert support and input to assigned projects and cross-functional initiatives.

Required Qualifications

• Doctor of Medicine (MD)
• Masters degree in Epidemiology Clinical Pharmacology or related field.
• Profound knowledge in Oncology esp. Treatment with Biologics.
• Hands on Experience with Biosimilars (during submission and post-marketing) and experience in people management

Preferred Qualifications

• Minimum 8 years industry experience in Pharmacovigilance preferably in a global role
• Fluency in English
• Broad and proficient understanding and experience in Pharmacovigilance operations and regulatory frameworks (esp. EU-GVP ICH) in the pharmaceutical industry or equivalent
• Experienced professional operating within the international arena and collaborating across functional areas and multicultural teams.

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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

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

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: