Pharmacovigilance Contractor: QPPV Support & Compliance

PTC Therapeutics; Craigavon; On-site; GBP 45,000 - 65,000; Full time

Job summary

A global biopharmaceutical company seeks a Pharmacovigilance Contractor to compile and author essential pharmacovigilance documents. This role requires a Bachelor's degree in Pharmacy or Life Sciences and at least 4 years of pharmacovigilance experience. The contractor will work closely with the QPPV office and collaborate with internal and external stakeholders. Strong regulatory knowledge and excellent communication skills are essential. This position is based in Craigavon, Northern Ireland and offers a dynamic and collaborative work environment.

Qualifications

• 4+ years of pharmacovigilance experience in pharmaceuticals or biotechnology.
• Expertise in FDA, EU, and ICH pharmacovigilance regulations.
• Experience authoring and compiling Pharmacovigilance System Master Files (PSMFs).

Responsibilities

• Compile and author the Pharmacovigilance System Master File (PSMF).
• Update and author Safety Data Exchange Agreements (SDEAs).
• Implement and apply Quality Management System for pharmacovigilance.

Skills

Pharmacovigilance experience

Quality Management System

Communication skills

Analytical thinking

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Microsoft Office

SharePoint

Job description

A global biopharmaceutical company seeks a Pharmacovigilance Contractor to compile and author essential pharmacovigilance documents. This role requires a Bachelor's degree in Pharmacy or Life Sciences and at least 4 years of pharmacovigilance experience. The contractor will work closely with the QPPV office and collaborate with internal and external stakeholders. Strong regulatory knowledge and excellent communication skills are essential. This position is based in Craigavon, Northern Ireland and offers a dynamic and collaborative work environment.