Pharmacovigilance Regulatory Intelligence Specialist (Biotechnology, Onsite)

Job summary

The role focuses on pharmacovigilance regulatory intelligence and process development within a newly established team dedicated to Patient Safety. The primary responsibility is to ensure the timely implementation of regulatory requirements from health authorities into internal processes, fostering compliance and continuous improvement in clinical safety.

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 regulatory requirements and translate them into practical procedures.

Responsibilities

• Lead regulatory intelligence activities related to pharmacovigilance and clinical safety.
• Evaluate the impact of new or updated regulations on Patient Safety processes and assist in implementation planning.
• Provide oversight and contribute to the strategy for Patient Safety procedures to ensure compliance.
• Act as a representative for Patient Safety in cross-functional project teams and process improvement initiatives.
• Participate in audits and health authority inspections, ensuring readiness and compliance.
• Communicate relevant regulatory updates to internal stakeholders and support change management efforts.

Skills

• Strong communication skills with the ability to engage effectively with internal and external stakeholders.
• High ethical standards and a strong quality mindset.
• Collaborative, proactive, and innovative approach with a positive attitude.

Education

• Master’s degree in a relevant field as mentioned in qualifications.

Tools

• Familiarity with regulatory compliance tools and methodologies in pharmacovigilance.