Pharmacovigilance and Scientific Information Manager
1 month ago
At Zentiva Group, we are a team of passionate professionals driven by our mission to deliver high-quality medicine to those who need it most. We strive to create a work culture where everyone feels valued, respected, and empowered to contribute their best. We welcome applications from talented individuals with diverse backgrounds, experiences, and perspectives, regardless of their religious or philosophical beliefs or personal choices.
About the Role
We are seeking a highly skilled Pharmacovigilance and Scientific Information Manager to join our team in the UK. As a key member of our Scientific Affairs team, you will provide expert guidance, leadership, and supervision to your direct reports, ensuring the highest standards of pharmacovigilance and scientific information management. Your primary responsibilities will include:
Pharmacovigilance:
- Maintain oversight of all UK PV cases, ensuring timely and accurate reporting to regulatory authorities.
- Act as the primary PV contact person for the MHRA, providing expert advice and support as needed.
- Monitor compliance of UK PV case and aggregate report submissions, ensuring adherence to regulatory requirements.
- Author and maintain the UK pharmacovigilance system master file (PSMF), ensuring accuracy and completeness.
- Ensure the UK Qualified Person for pharmacovigilance (QPPV) is kept informed of all UK PV-specific information.
- Be registered with and accessible to MHRA 24/7 in case of urgent safety situations.
- Maintain oversight of Medical Information (MI) management, ensuring high-quality delivery of MI and providing support to direct reports as needed.
- Provide expert support to direct reports for complex medical enquiries, ensuring accurate and timely responses.
- Ensure all MI SOPs/quality documents reflect the most 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 at all times.
- Adhere to company-defined processes for the selection of and agreement of commercial terms with vendors.
- Understand and use internal procedures and tools to ensure the compliant and efficient operation of the "Purchase to Pay" process.
- Performance manage the team through setting and reviewing priorities, providing timely feedback and coaching to help team members achieve their goals.
- Support the professional and career development of the team by identifying skills and competencies needed for current and prospective roles, providing opportunities to learn and practice new skills.
- Lead the building of a motivated and engaged team through the use of formal and informal recognition, regular communications, and encouraging cooperation between individuals and teams.
- 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.
- Competitive salary.
- Additional benefit package.
- International working environment and a passionate team of professionals.
- Continuous Learning & Development opportunities thanks to our Zentiva Academy.
At Zentiva Group, we strive to create a work culture where everyone feels valued, respected, and empowered to contribute their best. We welcome applications from talented individuals with diverse backgrounds, experiences, and perspectives, regardless of their religious or philosophical beliefs or personal choices.
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