Medical, Regulatory & PV Specialist
**Category**:Reg Affairs & Safety Pharmacovigilance
**Location**:Podgorica, Podgorica, RS
**The Position**
- As a Medical, Regulatory and Pharmacovigilance Specialist at Novo Nordisk, you will secure timely safety reporting in compliance with relevant requirements and maintain the pharmacovigilance (PV) system. You will directly report to General Manager Montenegro.
- You will also:
- Act as the safety responsible person in the affiliate for marketed products and clinical trials within Montenegro.
- Obtain regulatory approval of new products, maintain existing registrations, and continuously update regulatory files.
- Represent Novo Nordisk's vision, values, and commitments in daily interactions with external and internal customers.
- Ensure that local healthcare professionals are aware of and understand the scientific basis of our compounds in the diabetes area.
- Support business opportunities and strategic objectives, considering short, medium, and long-term local and national business needs.
**Qualifications**
- To be successful in this role, we expect you to have University Degree - pharmacy, medicine, or doctor of dental medicine.
- Experience in regulatory affairs and pharmacovigilance.
- Knowledge of local and international regulatory requirements.
- Strong communication and negotiation skills.
- Ability to work independently and as part of a team.
- Fluent spoken and written English.
**About the Department**
- You will be part of a dedicated team in Montenegro, working to ensure regulatory compliance and patient safety. Our department is responsible for obtaining regulatory approvals, maintaining product registrations, and safeguarding patients by ensuring the safety of our medicines. We work closely with health authorities and policymakers to shape future regulatory frameworks and support the availability of our products. The atmosphere is collaborative and dynamic, with a strong focus on achieving our goals and making a difference for patients.
**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.
**Contact**
**Deadline