Local Person for Pharmacovigilance (LPPV)

An opportunity has arisen for seasoned drug safety professional to join global leading CRO as LPPV.

The role is permanent, full-time and hybrid in either Buckinghamshire or Hertfordshire office, however, offers significant WFH flexibility.

You will be responsible for:

• Act as primary contact for PV for Competent Authority, including 24/7 availability if legally required
• Interface between the EU-QPPV / Global PV team and close cooperation with the global PV system of the client
• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• Local PSMF Maintenance
• Local PVA Management
• Local review and submission of PSURs / RMPs
• Local signal detection
• Integrated first Level Medical Information and PQC Support
• Participate in audits and inspections
• Issue, review and maintain pharmacovigilance SOPs and work instructions

You will bring:

• Life Science degree
• 5+ years of experience in Pharmacovigilance
• In-depth knowledge of drug safety regulations, industry practices and standards
• Ability to work independently with high sense of responsibility
• Team player
• Quality oriented approach and consistent attention to detail
• Excellent written and verbal communication skills

If you don’t want to miss out on this opportunity, please get in touch ASAP.

Email: Valerie.kalna@biotalent.com
Phone: 0203 892 8777