Position Purpose
The PV and Medical Affairs Manager provides pharmacovigilance and medical affairs expertise, leadership, mentorship, and supervision, and supports the management of medical, scientific, and administrative responsibilities.
The role is responsible for the development and implementation of PV and Medical Affairs strategy, processes, and platforms, ensuring compliance with legislation and company procedures and the efficient delivery of PV and Medical Affairs services.
Key Responsibilities and Duties
Pharmacovigilance
- Act as the UK National Contact Person for Pharmacovigilance (NCPP) and primary PV contact for the MHRA.
- Maintain oversight of all UK pharmacovigilance cases, including those received via health authorities.
- Monitor compliance of UK PV case management and aggregate report submissions.
- Author and maintain the UK Pharmacovigilance System Master File (PSMF).
- Ensure the UK Qualified Person for Pharmacovigilance (QPPV) is fully informed of all UK-specific PV information.
- Act as Local Pharmacovigilance contact for the UK and Ireland and oversee PV case management activities within timelines.
- Ensure compliance with risk management, signal detection, and safety updates requested by health authorities.
- Maintain up-to-date knowledge of Good Pharmacovigilance Practice (GvP), legislation, and industry best practices.
Medical Affairs
- Maintain oversight of Medical Information and Medical Affairs activities to ensure high-quality delivery.
- Provide support for complex medical enquiries and Medical Information activities.
- Support ethical compliance programmes in line with legislation and corporate guidelines.
- Take responsibility for medical compliance, including transparency reporting and approval of educational, promotional, and non-promotional materials and events.
- Support engagement with key opinion leaders, market research, and advisory boards.
Leadership and Collaboration
- Deputise for the Head of Scientific Affairs as required.
- Lead, develop, and motivate the team through performance management, coaching, and professional development.
- Represent the UK PV function internally and externally and collaborate with global PV and Medical Affairs teams.
- Lead and participate in PV, Medical Information, and Medical Affairs inspections and audits.
Qualifications & Required Skills
- Life science degree or qualification as a healthcare professional (e.g. pharmacist, pharmacy technician, nurse).
- Extensive experience within the pharmaceutical industry, including pharmacovigilance and medical or scientific affairs.
- Strong knowledge of pharmacovigilance guidelines, medicines legislation, and industry codes of practice.
- Proven ability to lead, manage, and develop teams.
- Strong organisational skills with the ability to manage multiple priorities and work to tight deadlines.
Our Recruitment Process
To be considered for this role, please apply via our Applicant Tracking System and refrain from sending your CV by email. Once the application period has closed, all applications will be reviewed by our recruitment experts and evaluated against the role requirements.
Selected candidates will be contacted for an initial screening interview, followed by interviews with line managers. Candidates not selected will be informed in writing as soon as possible.
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At Zentiva, we are a team of 5000 unique talents united by our purpose to provide health and well-being for all generations. We welcome applications from all qualified candidates, regardless of background, identity, or life experience.
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