Pharmacovigilance Specialist

JOB DESCRIPTION:

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Professional development with an international company where you can achieve the career you’ve always dreamed of.
• A company recognized as one of the best places to work in dozens of countries around the world and named one of the World’s Most Admired Companies by Fortune magazine.
• A company acknowledged as one of the best large companies for working mothers, women executives, and scientists, and where diversity is truly valued.

The Opportunity

This position works out of our Guatemala City location in the EPD division.

In the Established Products 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, differentiated branded generics spans multiple therapeutic areas, including gastroenterology, women’s health, cardiometabolic conditions, pain management/central nervous system, and respiratory care.

This is a temporary role- 1 yr contract.

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 in negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements.
• Support in due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization.
• Provision of local PV Compliance metrics and management of non-compliances.
• Support in the coordination/management of PV audits and inspections at the Affiliate level.
• Perform vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements.
• Perform PV quality checks requiring four-eye review.
• Follow the PVA between AN and EPD for processes related to reconciliation, metrics, compliance ICSRs reporting and HA submissions.

Required Qualifications

• Bachelor's degree in Pharmaceutical Chemistry (Graduated)
• 2-3 years of experience as pharmacovigilance specialist 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.

The base pay for this position is

N/A

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

     

JOB FAMILY:

Product Development

DIVISION:

EPD Established Pharma

LOCATION:

Guatemala > Guatemala : 5a Ave 5-55 Zona 14

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)