Pharmacovigilance and Regulatory Affairs Officer

Job description / Role

Job Purpose:
The main objective of this role is to manage products safety procedures, in accordance to the MOH Pharmacovigilance requirements and to act as Pharmacovigilance Officer ensuring accurate and prompt reporting of adverse event reported to AZM. The ideal candidate should hold a UAE MOH license with prior experience. Should have respect to confidentiality and business ethics, with a strong sense of ownership and commitment. The candidate must also have good negotiation, presentation and analytical skills with the ability to handle multiple tasks. Must have strong verbal and written communication skills in English.

Principle Accountabilities:

Internal & External:
• The Pharmacovigilance (PV) Officer is required:
• To report spontaneous ICSRS to Suppliers and Health Authority - create hard copy template for the PV Associate to adapt and distribute
• To report Suspected and Unexpected Serious Adverse Reactions to Health Authorities
• To perform ICSR reconciliation with business partners, if required
• To track ICSRs
• To write or contribute to PSURs and ADRs as required. This may include acting as the project coordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.
• To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required.

Technical Responsibilities:
• Substantial experience in a PV or compliance related role
• Deep understanding of pharmacovigilance and regulatory requirements.
• Sets high standards and with continuous attention to detail. Is able to operate objectively and independently, deciding when to escalate issues where appropriate

Administrative Responsibilities:
• Prepare and review all SOP’s P.V. plan for all our suppliers.
• Collect all the data of ADR’s essential to fill CIOMS forms.
• Fill CIOMS forms and report them to the Principle Company and relevant authorities.
• Represent the company in MOH and different authorities.
• Capable of communication with different suppliers and stakeholders to prepare registration files and P.V. forms.
• Prepare all the registration files to be submitted to MOH for medical, pharmaceuticals and GSL products.
• Provide leadership for the development, management and tracking of quality and compliance checks across the Company at regional and local level to ensure compliance.
• You will be responsible for Quality Control measures
• You will be responsible for the processing of data
• You will be responsible for the product complaint handling
• Provide Trainings to internal departments on PV Procedures and reporting

Requirements

Minimum Qualification:
• The PV Officer should be have Medical qualifications preferably a Pharmacist /Physician
• Deep understanding of pharmacovigilance and regulatory affairs.

Experience:
• The PV Officer should have a minimum of 2 years’ experience in Pharmacovigilance or related scientific area.
• 1 year experience in the same designation.
• MOH license is an added value

Job Specific Skills:
• The PV Officer will report to the WH & Regulatory Affairs Manager on other supportive responsibilities
• Responsible for Pharmacovigilance and Warehousing, on a day to day basis as needed.

Behavioral Capabilities:
• Key Attributes Self Starter Problem solving skills Accuracy and attention to details
• Effective organization skills and ability to prioritize Ability to work under pressure and to tight deadlines
• Ability to work under pressure and to tight deadlines
• Ability to work in a fast paced environment.
• Ability to manage projects in a matrixed team environment and with both internal and external partners

About the Company

Abul Qasim Khalaf Al Zahrawi (936-1013 A.D) known in the west as Abulcasis was born in Zahra in the neighborhood of Cordova (Arabic Qurtuba). He became one of the most renowned surgeons of his era and the Middle Ages. He is best known for his early and original breakthroughs in surgery as well as for his famous Medical Encyclopedia called Al-Tasrif, which is composed of thirty volumes covering different aspects of medical science.

The more important part of this series comprises three books on surgery, which describe in detail various aspects of surgical treatment as based on the operations performed by him, including cauterization, removal of stone from the bladder, dissection of animals, midwifery, styptics, and surgery of eye, ear and throat. He perfected several delicate operations, including removal of the dead fetus and amputation. Al Zahrawi is considered as Father of Modern Surgery.