Regulatory and Pharmacovigilance (PV) Specialist

Regulatory and Pharmacovigilance (PV) Specialist

The Headhunter LTD, a daughter company of The Headhunter Karriera USA, is looking for a Regulatory and Pharmacovigilance (PV) Specialist on behalf of its client, a leading global pharmaceutical company recognized for its innovation, quality standards, and commitment to patient care.

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 our client'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 the company's 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.

Our client 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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