Senior Pharmacovigilance Contractor

PTC Therapeutics; Guildford; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading biopharmaceutical company in Guildford seeks a Pharmacovigilance Specialist to manage PSMFs and collaborate with various departments for safety data management. The ideal candidate will have a degree in Life Sciences and at least 4 years of relevant experience in pharmacovigilance, alongside excellent communication and analytical skills. Proficiency in tools like Microsoft Office and Sharepoint is essential. Join a dynamic team dedicated to improving patient safety and quality standards.

Qualifications

• 4+ years of pharmacovigilance experience in a pharma or biotech environment.
• Expertise in FDA, EU, and ICH pharmacovigilance guidelines.
• Experience in authoring PSMFs.
• Hands-on experience in process improvements in pharmacovigilance.
• Strong planning and organization skills.

Responsibilities

• Compile and author the PSMF to ensure all national requirements are met.
• Collaborate with Supply Chain and Commercial teams for safety data exchange.
• Develop and revise SOPs/processes related to pharmacovigilance.
• Manage key PV documents in electronic systems.
• Ensure inspection readiness and lead pharmacovigilance audit responses.

Skills

Pharmacovigilance experience

Process improvement

Analytical thinking

Communication skills

Team collaboration

Problem-solving

Education

BSN/RN or Bachelor's degree in Pharmacy or Life Sciences

Tools

Microsoft Office

Sharepoint

Job description

A leading biopharmaceutical company in Guildford seeks a Pharmacovigilance Specialist to manage PSMFs and collaborate with various departments for safety data management. The ideal candidate will have a degree in Life Sciences and at least 4 years of relevant experience in pharmacovigilance, alongside excellent communication and analytical skills. Proficiency in tools like Microsoft Office and Sharepoint is essential. Join a dynamic team dedicated to improving patient safety and quality standards.