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Pharmacovigilance and Regulatory Affairs Specialist

Category: Regulatory

Location:

Dubai, Dubai, AE

Do you have the ability to work well within teams and across functions, developing collaborative relationships both internally and externally? Novo Nordisk has opened a role for a Pharmacovigilance and Regulatory Affairs Specialist, based in Dubai, United Arab Emirates (UAE), and directly reports to the Regulatory Affairs & Pharmacovigilance Manager.

Be part of our life-changing careers and apply today!

The position

As Pharmacovigilance and Regulatory Affairs Specialist, you will be responsible of all the pharmacovigilance activities in UAE and for Supporting the compiling, submission, and approval of Regulatory activities.

Main accountabilities will include:

• Maintenance and continuous improvement of the affiliate\'s PV system
• Training of Novo Nordisk UAE employees and external partners regarding safety aspects
• Handling safety agreements with partners and being the QPPV for UAE.
• Timeliness of reporting of Individual Case Safety Report ICSR and customer complaints to HQ and authority.
• Monitor the local regulatory environment and ensure regulatory compliance.
• Support in developing labelling materials and reviewing/approving promotional materials.
• Support the compiling, submission, and approval of New Drug Application (NDA) and Life Cycle Management (LCM) licenses.
• Ensuring audit and inspection readiness.

Qualifications

To be considered, you need to have a bachelor\'s degree in pharmaceutical studies, a minimum of 3 years of experience in Pharmacovigilance (Regulatory Affairs experience will be a plus), with Fluency in written and spoken English and Arabic, Other important requirements are:

• You hold QPPV certification.
• Has knowledge of local/global pharmacovigilance regulations.
• Strong communication and analytical skills.
• Technical Knowledge and Skills in Pharmacovigilance requirements and landscape.
• IT skills.
• Attentive to details.

About The Department

CMRQ department is including clinical and medical affairs functions responsible of all clinical and medical activities in the affiliate and the Regulatory Affairs & Pharmacovigilance functions responsible for all the regulatory activities related to the registration of pharmaceutical products and medical devices, keeping their life cycle management and the reporting the customer complaints, adverse events and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plan (RMPs) to the local authority.

Working at Novo Nordisk

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care, rare diseases, and other serious chronic diseases, we are proud to make a difference for millions of people around the world. We know that results are made together and that great opportunities for personal and professional growth are important to provide.

Contact

Please click on \'apply now\' to submit your resume in English.

Deadline

Apply before January 4, 2023.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

Novo Nordisk