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Regulatory Affairs & Pharmacovigilance Officer

Aspire MENA

Riyadh, Saudi Arabia

Ref: OP012-33

Job description / Role

Job Title: Regulatory Affairs & Pharmacovigilance Officer – Saudi Arabia
Location: Riyadh

Reports to: Regulatory Affairs Manager for MENA and Regional Regulatory Affairs team based in Dubai.

Purpose of the Job:
• Regulatory point of contact between the company, SFDA, GCC-DR and other competent authorities
• Person Locally Responsible for Pharmacovigilance (PhV) in Saudi Arabia
• Submissions, follow-up and compliance with respect to SFDA, GCC-DR and other competent authorities
• Input to the Dubai-based Regional Regulatory Affairs team of of the company about updated regulatory guidelines of the SFDA, GCC-DR and other relevant authorities
• Ensure that the company/ business complies with relevant regulations, policies and industry codes
• Contribute in the development and implementation of tactical action plans to achieve business objectives

Detailed Responsibilities
• To achieve timely submissions and approvals for registration/ re-registration/ variation for concerned sites and products at SFDA and/or GCC-DR
• To follow up actively on all submissions to ensure resolution of any arising issues
• To endeavor constantly to anticipate and respond to regulatory and technical queries from the competent authorities
• To assist in closure of deficiencies or observations from the competent authorities
• To maintain constant vigilance in the market to obtain guidance on registration updates, submission/ approval timelines, and new regulations in order to formulate effective regulatory strategies
• To update the Dubai teams about potential risks associated with regulatory submissions and prepare for contingency plans
• To forward to MENA team (for archival) all regulatory correspondence to and from the competent authorities
• To submit patent check application and obtain relevant patent results from patent offices in Saudi Arabia e.g. KACST or GCC-DR patent office as requested. If required, submit follow up documents e.g. Patent challenge file to respective patent office and obtain further comment or approval from the same
• To review product artwork and promotional material, as requested
• To perform and fulfill all pharmacovigilance (PV) obligations in Saudi Arabia as required by the local authority and in compliance with Corporate PV procedures
• To assist and liaise with the European QPPV (Qualified Person for Pharmacovigilance) in matters related to safety, contact with the local authority, updates in local Pharmacovigilance legislations and guidelines, Pharmacovigilance audits and inspections and adverse event management and reporting
• To forward to MENA team all medical inquiries (MIs) and/or product quality complaints (PQCs) received for company products in Saudi Arabia.
• To liaise with and accompany inspectors nominated by competent authorities for GMP inspections of sites which are pertinent to the business in Saudi Arabia or the MENA region for the purpose of ensuring favorable inspection outcomes
• To cultivate and maintain strong professional relationships with competent authorities, trade partners, key customers, tender bodies, hospitals, institutions as is pertinent to the business
• To assist, when requested, the Commercial Director in Saudi Arabia with market research and product surveys in support of business development initiatives
• To assist, when requested, the Commercial Director in Saudi Arabia with calls (visits) to customers such as Key Opinion Leaders (KOLs), Senior Purchasers, tender authorities and the like for the purpose of addressing any arising business concerns
• To coordinate the necessary actions and compile the required paperwork to enable the company to participate in regional or local tender events, such as, SGH, MODA, MOH, NG and other important institutional tenders
• To set up Scientific Office in Saudi Arabia and thereafter assume the role of Scientific Office Manager
• To fulfill all obligations as required by local law pertaining to Scientific Office Manager
• To adhere to all instructions and directives as issued by company
• To carry out duties in an ethical and professional manner at all times, thereby enhancing the company image

Requirements

As the Regulatory Affairs & Pharmacovigilance Officer you will be responsible in Saudi Arabia market. You will lead the tasks in complying with the guidelines, regulations policies and oversee the development and implement an action plan to achieve the business objectives.

You must have the following skills:

Relevant Skills and Experience:

Essential
• A national of Saudi Arabia
• Fluency in written and verbal Arabic and English
• 2- 3 years-experience in Pharmaceutical regulatory affairs and Pharmacovigilance in Saudi Arabia and GCC-DR
• A good working knowledge of SFDA and GCC-DR regulatory and Pharmacovigilance requirements
• Computer literate, familiar with computer-based information systems and artwork software, and new electronic documentation systems
• A deep knowledge of the pharmaceutical environment both from local and international perspectives

Desirable
• Prior experience with respect to setting up Scientific Office in Saudi Arabia
• Works well individually and within a team environment
• Strong capability to work under pressure and self-motivated
• Appreciation of cultural diversity
• Energetic, self-starter, and enjoys the thrill of the chase

About the Company

Aspire prides itself on its relationships with the MENA regions most accomplished professionals and we thrive on supporting the growth of local and multinational companies.

We believe in partnerships based upon a transparent and personable approach, enabling our clients access to the very best talent not available on the open market and our candidates with challenging and long lasting career opportunities.

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