Senior Pharmacovigilance Specialist: Regulatory & Safety Leader

Xeolas; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

A specialty Pharmaceutical company in Dublin is seeking an experienced Pharmacovigilance Senior Specialist to enhance their pharmacovigilance operations. The role involves overseeing safety case management and regulatory documentation, while also mentoring junior staff. Ideal candidates will have at least 5 years of experience in pharmacovigilance and a strong understanding of EU regulations. The position offers opportunities for strategic responsibilities and professional development.

Qualifications

• Minimum of 5 years' experience in pharmacovigilance.
• Proven experience in case processing and safety database management.
• Demonstrated ability to manage audits and inspections.

Responsibilities

• Oversee and execute pharmacovigilance activities.
• Draft, review, and finalize Pharmacovigilance Agreements.
• Ensure adherence to internal quality systems and regulations.
• Act as a key point of contact for clients.

Skills

Understanding of EU and global PV regulations

Excellent communication skills

Problem-solving skills

Organizational skills

Ability to work independently

Ability to work collaboratively

Education

Bachelor's degree in Life Sciences, Pharmacy, Medicine

Job description

A specialty Pharmaceutical company in Dublin is seeking an experienced Pharmacovigilance Senior Specialist to enhance their pharmacovigilance operations. The role involves overseeing safety case management and regulatory documentation, while also mentoring junior staff. Ideal candidates will have at least 5 years of experience in pharmacovigilance and a strong understanding of EU regulations. The position offers opportunities for strategic responsibilities and professional development.