Pharmacovigilance Regulatory Intelligence Specialist (Biotechnology, Onsite)

Job summary

This role focuses on pharmacovigilance regulatory intelligence and process development within a newly established team dedicated to Patient Safety. The position involves ensuring compliance with health authority requirements and contributing to the continuous improvement of clinical safety processes.

Qualifications

• Master's degree in Medicine, Veterinary Medicine, Pharmacy, Human Biology, or a related life science field
• Minimum of 5 years of experience in pharmacovigilance and clinical safety process development
• Proven ability to interpret and implement regulatory requirements into practical procedures
• Experience in cross-functional project teams and governance forums
• Strong communication skills for effective stakeholder interaction

Responsibilities

• Lead regulatory intelligence activities for pharmacovigilance and clinical safety
• Evaluate the impact of new or updated requirements on Patient Safety processes
• Oversee and contribute to the strategy for Patient Safety procedures
• Represent Patient Safety in audits and health authority inspections
• Communicate regulatory updates to internal stakeholders and support change management

Skills

• High ethical standards and a strong quality mindset
• Collaborative, proactive, and innovative approach
• Ability to assess process impacts and drive consistent implementation

Education

• Master's degree in a relevant field

Tools

• Experience with regulatory compliance tools and methodologies