Regulatory and Pharmacovigilance (PV) Specialist

Regulatory and Pharmacovigilance (PV) Specialist

Tirana, Albania

The HeadHunter Karriera LLC is an innovative Recruitment, Executive Search and HR Company with Headquarters in the USA, operating as a leader in Albania, Kosovo, Montenegro, Bulgaria, Canada, North Macedonia, Bosnia & Herzegovina, Greece, Serbia, and Cyprus. We offer the newest mentality in the HR industry, and our core businesses are Candidates and Clients.

For our Client: Novo Nordisk — a leading global healthcare company (https://www.novonordisk.com/) — we are looking for a Regulatory and Pharmacovigilance (PV) Specialist.

Are you an energetic, detail-oriented team player with a strong sense of quality and a proactive mindset? Do you enjoy solving problems, managing multiple priorities, and communicating clearly with internal and global stakeholders?

We are seeking a candidate to support regulatory submissions and pharmacovigilance activities, helping ensure Novo Nordisk's products are launched and maintained in the market in full compliance with applicable regulations.

In this role, you will:

• Prepare regulatory documents, dossiers, and applications for new product launches and ongoing maintenance.
• Maintain regulatory compliance databases, systems, and processes.
• Analyze regulatory issues and communicate clearly with key stakeholders, including global colleagues.
• Proofread labelling items.
• Prepare PV documentation in line with Novo Nordisk procedures and regulatory requirements.
• Collect and report safety information in internal systems and to local agency.
• Support PV audit/inspection readiness and help prepare for PV audits and health authority (HA) inspections.
• Collaborate with cross-functional teams within the organization.

Your skills and qualifications:

• Degree in pharmacy or medicine and at least 3 years of experience in the regulatory and pharmacovigilance field.
• Quality mindset with experience supporting audits/inspections.
• Strong time management, analytical thinking, and problem-solving skills.
• Fluency in English (written and spoken).
• Experience with Veeva RIM (or similar Registration Information Management systems) is a plus.
• Regulatory and PV experience for Kosovo is a plus.

Compensation & benefits:

• Stable and competitive salary, aligned with your experience and performance.
• Strong, values-driven company environment with a well-organized business system and long-term stability.
• Opportunities for professional development and career growth, including learning programs and structured onboarding.
• Modern tools and equipment, along with all necessary resources to support high-quality work.
• A collaborative and supportive work culture, built on mutual respect, inclusion, and teamwork.
• Private health insurance.
• Employee wellbeing initiatives.

Novo Nordisk is an Equal Opportunity Employer and is committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, age, national origin, disability, sexual orientation, gender identity, or any other characteristic protected by applicable law.

If this opportunity aligns with your experience and career aspirations, please apply directly through this job posting.

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