At a Glance
- Tasks: Lead pharmacovigilance and medical affairs, ensuring compliance and high-quality service delivery.
- Company: Dynamic pharmaceutical company focused on innovation and patient safety.
- Benefits: Competitive salary, professional development, and opportunities for leadership.
- Other info: Join a collaborative team with excellent growth potential and mentorship opportunities.
- Why this job: Make a real impact in healthcare while developing your career in a supportive environment.
- Qualifications: Life science degree and experience in pharmacovigilance or medical affairs required.
The predicted salary is between 60000 - 75000 £ per year.
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 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 (Gv P), 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 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. #J-18808-Ljbffr
