Pharmacovigilance Specialist

Pharmacovigilance Specialist, this position is based in Guatemala City, Guatemala.

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.

• Sales Incentive Plan

• 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 is based in Guatemala City. As the Pharmacovigilance Specialist you will be responsible for supporting the Affiliate Safety Representative (ASR) ASR/ASR back up in local pharmacovigilance activities related to both Abbott EPD investigational and registered medicinal products. During absence of the ASR/ASR back-up this person ensures that all pharmacovigilance activities are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. This includes interactions with local health authorities and representation of pharmacovigilance internally within the Affiliate organization.

What You’ll Do

• Acts as a local pharmacovigilance responsible person before the Authority, if designated by the ASR. 

• Collaboration for the maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates.

• PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.

• Receipt, recording, and reconciliation of safety information.

• Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans.

• Regulatory submission of safety information.

• Basic PV training of local Abbott Nutrition and Abbott Established Product staff.

• PV record retention and archiving.

• Implementation of out-of-office coverage for receiving and recording safety-relevant information.

• Support in the maintenance of local PV product list.

• Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes.

• Support the oversight and coordination of activities delegated to Abbott in LATAM in accordance with the

  Pharmacovigilance Agreement (PVA) between EPD and AN. divisions.

• Perform reconciliation of activities in accordance with the periodicity and terms established in the PVA.

• Compilation of metrics/data related to pharmacovigilance activities and forwarding to management as requested and/or in compliance with the terms established in the PVA.

• Support AN ASR in LATAM in the execution of local pharmacovigilance activities (restricted to products in the portfolio registered as pharma) as per PVA including training of affiliate staff, contacting reporters for follow up, managing reporting platforms and forms, reconciliations, archiving and record retention.

• Support in overseeing compliance of submission of ICSRs received for Abbott Nutrition products covered by the PVA in a compliant and timely manner. Ensures that any regulatory submissions associated with products registered as pharma are handled, processed, and submitted according to applicable regulations and in accordance with the established terms in the PVA.

Required Qualifications

• Bachelor's degree in Pharmaceutical Chemistry (Graduated)

• 2-3 years of experience as pharmacovigilance analyst or similar is required; experience in pharmaceutical company is preferred

• Understanding of local pharmacovigilance regulation.

• Ability to give attention to the detail.

• Computer literacy (Windows, MS Office).

• Proficiency English language skills.

• Good communication skills with internal and external stakeholders.

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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 www.abbott.com, on Facebook at www.facebook.com/Abbott 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.