Pharmacovigilance Manager (Operations)

Proclinical is seeking a Pharmacovigilance Manager to be based in Copenhagen on a permanent basis.

Job Responsibilties:

• Drive the PV function to ensure that PV-related activities related to clinical studies are performed by trained personnel and compliant with applicable safety reporting requirements
• Maintain oversight of regulatory reporting requirements
• Develop and maintain a compliance monitoring system
• Regular collaboration with, and support to, Head of Clinical Safety
• Regular collaboration with clinical research organizations (CROs) and other PV-service providers
• Contribution to marketing authorization registration dossier from a drug safety perspective
• Contribution to the preparation and update of PV standard operating procedures and working instructions
• Ensure up-to-date PV knowledge
• Provide operational/scientific support to the production of scientific reports etc
• Provide sponsor oversight to the ICSR process and the global safety database
• Contribute to agreements within clinical safety area

Skills and Requirements:

• Good ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Ability to review many documents while maintaining consistency and attention to details
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
• Good written and oral communication skills
• Well organized and structured
• Ability to drive projects and deliver results
• Good understanding of pharmacovigilance requirements in clinical trials

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.