Especialista de Farmacovigilancia

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

PRIMARY FUNCTION:
Responsible for the execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie’s statutory and ethical responsibilities are met. The primary responsibility of this role is to receive, evaluate, investigate, document, and carry out all activities related to adverse events and safety information concerning pharmaceutical products and combined products in compliance with all applicable regulatory requirements.

RESPONSIBILITIES:

• Escalate compliance issues and potential PV resource issues in a timely manner to the Affiliate Safety Representative (ASR) and PV manager.
• Receives and evaluates safety notifications regarding pharmaceutical products and combined products.
• Triages and classifies safety notifications into initial cases or follow-up to an existing case.
• Register cases into the applicable tracking system.
• Using the appropriate system completes and submits initial safety reports within the established timelines to be in compliance with applicable regulations.
• Requests additional information to the reporter and submits follow-up reports as required, in compliance with applicable regulations. Maintains records of contact according to established procedures.
• Consults, when necessary, with the Medical Director or with the Affiliate Safety Representative (ASR) the seriousness and causality of the medical event.
• Performs quality check to PV processes for compliance with established requirements
• Work with ASR and PV manger to ensure that local Affiliate is ready for internal PV audits and Regulatory Agency PV inspections.
• Conduct PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements
• Understand and monitor incoming local safety data to the ASR and PV Manger for evaluation.

• Bachelor's degree in health/science discipline.
• Minimum of 1 year of experience is desirable.
• Good writing and oral skills in English and Spanish.
• Computer proficient with Microsoft programs particularly Word and Excel.
• Ability to work with multiple priorities in a work environment with frequent interruptions.
• Ability to perform teamwork

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.