Pharmacovigilance and Scientific Information Management Specialist
3 weeks ago
We are seeking a highly skilled Pharmacovigilance and Scientific Information Manager to join our team at Zentiva Group. As the UK National Contact Person for Pharmacovigilance, you will maintain oversight of all UK PV cases and ensure compliance with regulatory requirements.
Main Responsibilities:
- Act as the primary PV contact person for the MHRA
- Monitor compliance of UK PV case and aggregate report submissions
- Author and maintain the UK pharmacovigilance system master file (PSMF)
- Ensure that the UK Qualified Person for pharmacovigilance (QPPV) is kept fully aware of all UK PV specific information
- Be registered with and accessible to MHRA 24/7 in case of urgent safety situations
Additional responsibilities:
- Act as the Local Pharmacovigilance (LPV) contact for UK and Ireland
- Oversee PV case management of direct reports to ensure all PV cases are sent to Global Pharmacovigilance (GPV)/ Business partners within timelines
- Maintain all PV Standard Operating Procedures (SOPs)/quality documents to ensure they reflect the most efficient processes and are in line with regulatory and GPV requirements
- Review and oversee management of local Safety Data Exchange Agreements (SDEAs) by direct reports
- Ensure compliance of all PV activities including risk management and signal detection
Requirements:
- Life science degree or qualified Health Professional (e.g. pharmacy technician, pharmacist, nurse)
- 5-10 years' experience within pharmacovigilance
- Previous line management responsibilities would be advantageous
What we offer:
- Competitive salary
- Additional benefit package
- International working environment and a passionate team of professionals
- Continuous Learning & Development opportunities thanks to our Zentiva Academy
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