Medical and Regulatory Expert
3 days ago
We are seeking a highly skilled Pharmacovigilance and Scientific Information Manager to lead our team at Zentiva Poland.
About the Role:This is an exciting opportunity for a seasoned professional with experience in pharmacovigilance and scientific information management. As a Pharmacovigilance and Scientific Information Manager, you will be responsible for providing expert guidance and support to direct reports on PV and SI matters, ensuring compliance with regulatory requirements and industry best practices.
The ideal candidate will have 5-10 years of experience within pharmacovigilance, excellent leadership skills, and the ability to work collaboratively as part of a global team.
Responsibilities:Key Responsibilities:
- Author and maintain the UK pharmacovigilance system master file (PSMF).
- Ensure the UK Qualified Person for pharmacovigilance (QPPV) is kept aware of all UK PV specific information.
- Be registered with and accessible to MHRA 24/7 in case of safety situations.
- Act as the Local Pharmacovigilance (LPV) contact for UK and Ireland.
- Oversee PV case management of direct reports to ensure cases are sent to Global Pharmacovigilance (GPV)/ Business partners within timelines.
- Maintain all PV Standard Operating Procedures (SOPs)/quality documents to ensure they reflect 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.
- Represent the UK PV department internally and externally at a global level and function as an authoritative and professional member of the Scientific Affairs team.
- Maintain and provide a current understanding of Good Pharmacovigilance Practice (GvP)/legislation and industry best practices.
- Ensure all PV processes and data are kept in an inspection and audit ready condition.
Scientific Information:
- Maintain oversight of Medical Information (MI) management to ensure high quality delivery of MI and provide support to direct reports as required.
- Provide support to direct reports for complex medical enquiries.
- Ensure all MI SOPs/quality documents reflect efficient processes and are in line with regulatory and Zentiva global medical requirements.
- Ensure all SI processes and data are kept in an inspection and audit ready condition.
Team Management:
- Performance manage the team through setting and reviewing priorities.
- Provide appropriate and timely feedback about performance and coach team members to help them achieve their goals.
- Support the professional and career development of the team.
- Lead the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams.
Requirements:
- Estimated salary: €110,000 - €150,000 per annum, depending on qualifications and experience.
- 5-10 years' experience within pharmacovigilance.
- Competitive benefits package.
- Continuous Learning & Development opportunities.
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