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- Tasks: Lead a team ensuring compliance with pharmacovigilance regulations in the UK and EU.
- Company: Join a dynamic pharmaceutical company committed to patient safety.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on drug safety and patient health across Europe.
- Qualifications: Life science degree and significant pharmacovigilance experience required.
- Other info: Collaborative environment with strong focus on compliance and quality.
The predicted salary is between 48000 - 72000 £ per year.
The Pharmacovigilance (PV) Team Leader is responsible for ensuring that the Marketing Authorisation Holder (MAH) meets all pharmacovigilance obligations in the UK and EU. This role provides operational and compliance oversight of outsourced pharmacovigilance service provider, ensuring that all PV activities are conducted in accordance with UK and EU legislation, GVP requirements, and company procedures.
Key Responsibilities
- MAH Pharmacovigilance Responsibilities (UK & EU)
- Ensure the MAH fulfils all pharmacovigilance obligations in compliance with EU GVP Modules, UK Human Medicines Regulations and MHRA requirements.
- Act as the MAH's operational PV representative for UK and EU markets.
- Ensure continuous compliance with PV legislation throughout the product lifecycle.
- Support the Qualified Person for Pharmacovigilance (QPPV) / UK QPPV in maintaining oversight of the PV system.
- Ensure appropriate PV agreements are in place and maintained with partners, distributors, and service providers.
- Oversight of Outsourced Pharmacovigilance Service Provider
- Provide day-to-day oversight of outsourced PV provider delivering: Individual Case Safety Report (ICSR) management, Literature screening, Signal detection support, Aggregate reports (PSUR/PBRER, DSUR where applicable).
- Monitor vendor performance against contractual obligations, KPIs, and SLAs.
- Review and approve PV deliverables from service providers to ensure quality and compliance.
- Lead regular vendor governance meetings and document outcomes.
- Ensure issues, deviations, and CAPAs are appropriately managed and tracked.
- Case Management & Safety Reporting Oversight
- Ensure timely and compliant reporting of ICSRs to EudraVigilance, MHRA, and other relevant authorities and partners.
- Oversee case processing workflows, including case validation, medical review, and regulatory submission timelines.
- Ensure local reporting requirements in the UK and EU are met.
- Safety Reporting & Risk Management
- Oversee the review and confirm submission of PSURs / PBRERs, Risk Management Plans (RMPs) and updates, and signal management documentation.
- Ensure safety signals are detected, evaluated, and escalated appropriately.
- Support benefit-risk evaluations and safety communications as required.
- PV Quality System & Compliance
- Maintain and oversee the MAH PV Quality Management System.
- Ensure PV SOPs are current, compliant, and effectively implemented.
- Support PV inspections and audits by MHRA, EMA, and partners or internal audit teams.
- Manage inspection readiness activities, responses, and CAPAs.
- Ensure PV training requirements are defined, delivered, and documented.
- Cross-Functional & Regulatory Interaction
- Act as a key PV contact for internal stakeholders including Regulatory Affairs, Quality, and Commercial.
- Support regulatory submissions and variations from a PV perspective.
- Ensure safety information is appropriately reflected in product information (SmPC, PIL).
Qualifications & Experience
- Essential
- Life science degree (e.g., Pharmacy, Medicine, Biomedical Science).
- Significant experience in pharmacovigilance within the UK and/or EU.
- Strong knowledge of EU GVP Modules, UK PV legislation and MHRA requirements.
- Demonstrated experience overseeing outsourced PV vendors.
- Experience working within an MAH environment.
- Familiarity with inspections and audits (MHRA, EMA, EU NCAs).
- Skills & Competencies
- Strong regulatory and compliance mindset.
- Excellent vendor management and communication skills.
- Attention to detail and ability to manage multiple priorities.
- Ability to work independently and make sound compliance-based decisions.
- Strong documentation and review skills.
- Desirable
- Experience in both post-marketing and new submissions in the generic space.
- Exposure to global PV operations.
- Experience with electronic safety databases and EudraVigilance submissions.
Pharmacovigilance (PV) Team Leader in Ruislip employer: B&S Group
Contact Detail:
B&S Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance (PV) Team Leader in Ruislip
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmacovigilance field, attend industry events, and join relevant online forums. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU GVP Modules and UK PV legislation. Be ready to discuss your experience with vendor management and compliance oversight, as these are key areas for the PV Team Leader role.
✨Tip Number 3
Showcase your skills through real-life examples during interviews. Talk about specific situations where you ensured compliance or improved vendor performance. This will help us see how you can add value to our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Pharmacovigilance (PV) Team Leader in Ruislip
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Pharmacovigilance Team Leader role. Highlight your relevant experience in pharmacovigilance, especially within the UK and EU, and showcase your knowledge of GVP modules and MHRA requirements.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your experience overseeing outsourced PV vendors and managing compliance, and don’t forget to express your passion for pharmacovigilance!
Showcase Your Skills: We want to see your strong regulatory mindset and excellent vendor management skills shine through. Use bullet points to clearly outline your competencies and how they relate to the responsibilities listed in the job description.
Apply Through Our Website: Don’t forget to apply 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 you’re keen on joining the StudySmarter team!
How to prepare for a job interview at B&S Group
✨Know Your Regulations
Make sure you brush up on the EU GVP Modules and UK Human Medicines Regulations. Being able to discuss these regulations confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Vendor Management Insights
Prepare examples of your experience with overseeing outsourced pharmacovigilance service providers. Highlight specific instances where you monitored performance against KPIs or managed vendor relationships, as this is crucial for the role.
✨Demonstrate Attention to Detail
Since this role requires a strong focus on documentation and compliance, be ready to discuss how you've ensured quality in past projects. Bring up any experiences where your attention to detail made a significant impact on safety reporting or case management.
✨Showcase Cross-Functional Collaboration
Think of examples where you've worked with different teams, like Regulatory Affairs or Quality. Being able to illustrate your ability to communicate and collaborate across functions will demonstrate that you're a team player who can handle the complexities of pharmacovigilance.
