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 a supportive work environment.
- Other info: Join a diverse team committed to excellence and continuous improvement.
- Why this job: Make a real impact in healthcare while leading a passionate team.
- Qualifications: Life science degree and extensive experience in pharmacovigilance and medical affairs.
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 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.
Equal Opportunity: We welcome applications from all qualified candidates, regardless of background, identity, or life experience.
Pharmacovigilance & Medical Affairs Manager in Guildford employer: Dormont Manufacturing Co
As a leading employer in the pharmaceutical industry, we pride ourselves on fostering a collaborative and innovative work culture that prioritises employee growth and development. Our team members benefit from comprehensive training programmes, mentorship opportunities, and the chance to engage with key opinion leaders in the field, all while working in a dynamic environment that values compliance and excellence in pharmacovigilance and medical affairs. Located in the heart of the UK, we offer a supportive atmosphere where your contributions directly impact patient safety and healthcare outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance & Medical Affairs Manager in Guildford
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We think you need these skills to ace Pharmacovigilance & Medical Affairs Manager in Guildford
Some tips for your application 🫡
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Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Dormont Manufacturing Co that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Dormont Manufacturing Co!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Dormont Manufacturing Co, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Dormont Manufacturing Co
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Dormont Manufacturing Co that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Dormont Manufacturing Co’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
