Job Description

JOB DESCRIPTION:
Pharmacovigilance Specialist
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:
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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Dubai location.
Divisional Information
Established Pharmaceuticals
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.
Primary Job Function:
The Affiliate Safety Representative Back Up (ASR BU) in GEM and Egypt ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at cluster level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. The ASR further is the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization.
Core Job Responsibilities:

• Acts as a local contact point on a 24/7/365 basis in UAE.
• Support of Sr. PV Specialist - GEM with 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 EPD staff
• PV record retention and archiving
• Implementation of out-of-office coverage for receiving and recording safety-relevant information
• Maintenance of local PV product list
• Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes.
• Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
• Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization.
• Provision of local PV Compliance metrics and management of non-compliances
• Coordination/management of PV audits and inspections at the Affiliate level
• Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements.

Position Accountability/Scope:
The role takes responsibility for implementation and maintenance of a functional and compliant local PV system:

• Implementation of local legislative and Abbott internal requirements in GEM affiliate (UAE, Kuwait, Bahrain, Qatar, Oman, Iran, Iraq, Yemen, Lebanon, Jordan, Syria) and Egypt during the absence of the ASRs.
• Local PV interface to Health Authorities
• PV point of contact for Affiliate non-PV functions and GPV headquarter.
• Works in collaboration with local non-PV stakeholders to maintain a timely and complete exchange of PV-relevant information.
• Supports the Sr. PV Specialist - GEM, Manager PV Regional or GPV headquarter for specific global projects, as assigned.

Minimum Education:
Ideally graduate with a Life Sciences or Pharmacy degree or equivalent qualification.
Minimum Experience/Training Required:

• PV experience in pharmaceutical company is preferred.
• Understanding of local PV regulation.
• Ability to give attention to the detail.
• Computer literacy (Windows, MS Office).
• Good English language skills.
• Good communication skills with internal and external stakeholders.

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.
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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: United Arab Emirates
Dubai : Dubai Airport Freezone, Building 5WA, Floor 8
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Yes, 75 % of the Time
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Not Applicable

Skills Required