Pharmacovigilance Specialist

16 Ноября

Партнерские Вакансии

Компания "Ново Нордиск"

Are you passionate about patient safety? Do you have experience in pharmacovigilance and regulatory compliance? We are looking for a Pharmacovigilance (PV) Specialist to join our dynamic and diverse team in Novo Nordisk CIS Emerging Markets (CEM). If you are ready to make a difference in a rapidly changing environment, read on and apply today for a life-changing career.

The position

As a PV Specialist , you will establish and maintain a local pharmacovigilance (PV) system to support patient's and clinical trial subject’s safety in CEM, coordinate the overall pharmacovigilance activities and ensure compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes in CEM countries.

You will have the following responsibilities:

• Having full affiliate oversight of PV compliance activities, including mapping the process and responsibilities. Govern external party management, including Distributing Companies, Call Centre, and local partnerships from a patient safety perspective.

• Ensuring compliance in reporting safety information to/from relevant internal and external systems, as well as CEM countries Health Authorities. Contributing to benefit-risk assessment of Novo Nordisk product portfolio.

• Providing PV input to local/regional innovative drug development and marketing activities such as Compassionate Use Programs, Non-Trial activities, Non-Interventional Studies, supporting Customer Engagement Projects from a patient safety perspective in liaison with Global PV

• Establishing close collaboration with QA counterparts to ensure qualification of external PV partners, ensuring local PV inspection readiness and participation in PV audits and local PV inspections

• Follow good documentation and data integrity principles in accordance with Novo Nordisk and local requirements. Acts as local PV point of contact person (local QPPV) for the national Health Authorities as legally required.

Qualifications

To be our new PV Specialist, you must possess the following qualifications:

• A high level of education (e.g., pharmaceutical or medical degree, a life science degree is also acceptable).

• At least 2 years of experience in Pharmacovigilance in relevant countries.

• Knowledge of regulatory environment and local legislation in CEM.

• Proven capacity to handle multiple tasks, possessing strong organizational, communication, and prioritization abilities, along with a proactive and assertive approach, and a talent for well-balanced decision-making.

• Confident PC and IT systems user.

• Upper Intermediate English language skills (both written and spoken).

About the department

Novo Nordisk CIS Emerging Markets is part of Business Area Middle East, Africa, and Commonwealth of Independent States (BAMEAC). Based out of Almaty (Kazakhstan), Novo Nordisk CIS Emerging Markets is a highly diverse organization consisting of nine countries: Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan, Turkmenistan, Uzbekistan. Our team is dynamic and brave, energized by overcoming challenges and bringing new solutions in a rapidly changing environment. We aim to have a healthy, engaging, diverse, and fully inclusive company where employees can perform at their best, benefiting from different perspectives and backgrounds.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.