At a Glance
- Tasks: Lead pharmacovigilance efforts, ensuring compliance and safety throughout the product lifecycle.
- Company: Join a leading pharmaceutical company dedicated to patient safety and regulatory excellence.
- Benefits: Attractive salary, health benefits, flexible working options, and opportunities for professional growth.
- Why this job: Make a real difference in patient safety while developing your leadership skills in a dynamic environment.
- Qualifications: Experience in pharmacovigilance and strong leadership abilities are essential.
- Other info: Collaborative culture with a focus on continuous improvement and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
This role acts as the Pharmacovigilance lead for the Marketing Authorisation Holder (MAH), ensuring all UK and EU pharmacovigilance obligations are met throughout the product lifecycle. The position provides operational and compliance oversight of outsourced pharmacovigilance service providers and ensures activities are delivered in line with EU GVP, UK legislation, MHRA requirements, and internal procedures.
The PV Team Leader represents the MAH on day‑to‑day pharmacovigilance matters and works closely with the QPPV and UK QPPV to maintain effective oversight of the PV system. This includes maintaining pharmacovigilance agreements with partners, distributors, and vendors, and ensuring ongoing compliance across all products.
A key part of the role is the oversight of outsourced PV providers. This includes monitoring performance against KPIs and SLAs, reviewing and approving PV deliverables, leading regular governance meetings, and ensuring any issues, deviations, or CAPAs are identified, managed, and closed appropriately.
The role also oversees safety case management and regulatory reporting activities. This includes ensuring accurate and timely ICSR reporting to EudraVigilance, MHRA, and other relevant authorities, as well as overseeing case validation, medical review, and submission timelines to meet UK and EU reporting requirements.
In addition, the PV Team Leader oversees aggregate safety reporting and risk management activities, including PSURs, PBRERs, Risk Management Plans, and signal management documentation. They ensure safety signals are detected, evaluated, escalated appropriately, and contribute to benefit‑risk assessments and safety communications where required.
From a quality and compliance perspective, the role maintains the MAH pharmacovigilance quality management system, ensures PV SOPs remain current and effective, and supports PV inspections and audits conducted by the MHRA, EMA, partners, or internal audit teams. This includes maintaining inspection readiness, managing responses, and overseeing CAPA activities, as well as ensuring PV training requirements are completed and documented.
The role works cross‑functionally with Regulatory Affairs, Quality, and Commercial teams, providing pharmacovigilance input into regulatory submissions and variations. It also ensures that safety information is accurately reflected in product information such as SmPCs and PILs, while supporting continuous improvement of pharmacovigilance systems and processes.
Pharmacovigilance (PV) Team Leader employer: B&S Group (Laxmico Ltd)
Contact Detail:
B&S Group (Laxmico Ltd) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance (PV) Team Leader
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU GVP and UK legislation. We recommend practising common interview questions related to pharmacovigilance to show you’re the right fit for the team leader role.
✨Tip Number 3
Showcase your leadership skills! During interviews, share examples of how you've successfully managed teams or projects in the past. We want to see how you can lead the PV team effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see your passion for pharmacovigilance shine through!
We think you need these skills to ace Pharmacovigilance (PV) Team Leader
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Pharmacovigilance Team Leader role. Highlight your experience with compliance oversight, safety case management, and any relevant KPIs you've managed. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about pharmacovigilance and how you can contribute to our team. Be sure to mention your experience with EU GVP and UK legislation, as these are key for us.
Showcase Your Leadership Skills: As a Team Leader, we need someone who can lead and inspire. In your application, share examples of how you've successfully managed teams or projects in the past. This will help us see your potential to oversee our outsourced PV providers.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at B&S Group (Laxmico Ltd)
✨Know Your Pharmacovigilance Inside Out
Make sure you’re well-versed in the latest UK and EU pharmacovigilance regulations. Brush up on GVP guidelines, MHRA requirements, and any recent changes in legislation. This knowledge will not only impress your interviewers but also show that you’re serious about compliance.
✨Showcase Your Leadership Skills
As a PV Team Leader, you'll need to demonstrate your ability to lead and manage teams effectively. Prepare examples of how you've successfully overseen projects or teams in the past, particularly in a pharmacovigilance context. Highlight your experience with KPIs, SLAs, and governance meetings.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about potential challenges in pharmacovigilance oversight, such as managing CAPAs or ensuring compliance during audits. Prepare to discuss how you would handle these situations, showcasing your analytical and strategic thinking.
✨Cross-Functional Collaboration is Key
This role requires working closely with various teams like Regulatory Affairs and Quality. Be prepared to discuss your experience in cross-functional collaboration. Share specific instances where you’ve successfully worked with other departments to achieve common goals, especially in relation to safety reporting and regulatory submissions.