At a Glance
- Tasks: Lead and maintain a robust Pharmacovigilance Quality Assurance programme ensuring compliance and patient safety.
- Company: Join a pioneering pharmaceutical company dedicated to innovative healthcare solutions.
- Benefits: Hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with a focus on continuous improvement and creative problem-solving.
- Why this job: Make a real impact on patient safety while collaborating with industry leaders.
- Qualifications: Extensive experience in Pharmacovigilance Quality Assurance and strong stakeholder management skills.
The predicted salary is between 80000 - 100000 € per year.
We are looking for an experienced Pharmacovigilance Quality Assurance Director to lead and maintain a robust PV Quality Assurance programme, ensuring that pharmacovigilance activities supporting our products remain fully compliant with global regulations and internal quality standards. In this senior role, you will act as a trusted quality and compliance partner, providing oversight, assurance and strategic guidance across the pharmacovigilance system. You will work closely with senior stakeholders, quality teams, and service providers to identify risk, drive continuous improvement and, most importantly, ensure patient safety.
Key Responsibilities
- Provide independent quality assurance and oversight of pharmacovigilance processes to ensure compliance with global PV legislation, company policies and regulatory expectations.
- Lead and manage the PV QA programme, including audit risk assessments, audit planning, execution oversight and follow-up.
- Oversee and track Corrective and Preventive Actions (CAPAs), verifying effectiveness and escalating risks or issues where required.
- Act as a key point of contact for PV inspection readiness and inspection management, ensuring teams are fully prepared and supported.
- Review and oversee audit outcomes that impact supported products, including those conducted by internal and external quality functions.
- Partner with senior leadership to identify quality, compliance and risk areas, agreeing and monitoring remediation plans.
- Maintain and develop Pharmacovigilance System Master File (PSMF) content related to audit and deviation management.
- Generate and present quality metrics, reports and insights to governance and oversight forums.
- Provide expert advice on PV compliance, quality improvement, risk assessment and regulatory interpretation.
- Support the ongoing development of the Quality Management System (QMS) underpinning pharmacovigilance activities.
- Build and maintain strong working relationships across internal quality and compliance teams and with external partners.
- Contribute to and deliver training programmes within your area of expertise.
About You
We are looking for a high energy individual who can bring their market preparation and launch excellence expertise to this pivotal role. Pioneering new approaches, creative thinking and helping us to differentiate ViiV. To be successful in this role, you will bring:
- Extensive experience in Pharmacovigilance Quality Assurance, PV compliance or regulatory quality within the pharmaceutical or biotechnology industry.
- Strong knowledge of global PV and GCP legislation, regulatory guidelines and inspection expectations.
- Proven experience managing PV audits, inspections and CAPAs.
- Confidence engaging with and influencing senior stakeholders on quality, risk and compliance matters.
- Excellent analytical, communication and stakeholder management skills.
- A proactive, collaborative mindset with a strong focus on patient safety and continuous improvement.
Location and Working Pattern
This role is based at our UK HQ in Central London, and operates on a hybrid working model. You will be expected to work on-site 2/3 days per week to collaborate with cross-functional teams and support critical activities.
Pharmacovigilance Quality Assurance Director employer: GlaxoSmithKline
At ViiV, we pride ourselves on being an exceptional employer, offering a dynamic work environment in the heart of Central London. Our commitment to employee growth is evident through our robust training programmes and collaborative culture, where innovation and patient safety are at the forefront. With a hybrid working model, we ensure flexibility while fostering strong relationships across teams, making it a rewarding place for professionals in Pharmacovigilance Quality Assurance to thrive.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance Quality Assurance Director
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmacovigilance field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a job opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global PV legislation and compliance standards. Be ready to discuss how you've tackled challenges in past roles, especially around audits and CAPAs. Show them you’re the expert they need!
✨Tip Number 3
Don’t just apply anywhere—apply through our website! We want to see your application and get to know you better. Plus, it shows you’re genuinely interested in joining our team at StudySmarter.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that can set you apart from other candidates. Mention something specific from your conversation to remind them why you’re the perfect fit for the role.
We think you need these skills to ace Pharmacovigilance Quality Assurance Director
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Pharmacovigilance Quality Assurance Director role. Highlight your relevant experience in PV compliance and quality assurance, and don’t forget to showcase your knowledge of global regulations!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that demonstrate your ability to lead and manage PV QA programmes effectively.
Showcase Your Stakeholder Engagement Skills:In your application, emphasise your experience in engaging with senior stakeholders. We want to see how you've influenced quality and compliance matters in the past, so share those success stories!
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 this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at GlaxoSmithKline
✨Know Your Regulations
Make sure you brush up on global pharmacovigilance (PV) legislation and Good Clinical Practice (GCP) guidelines. Being able to discuss these confidently will show that you’re not just familiar with the rules, but that you can apply them effectively in your role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed PV audits or inspections. Highlight how you handled CAPAs and what strategies you implemented to ensure compliance. This will demonstrate your hands-on experience and problem-solving skills.
✨Engage with Stakeholders
Think about how you’ve influenced senior stakeholders in previous positions. Be ready to share stories that illustrate your communication skills and ability to build relationships. This is crucial for a role that requires collaboration across various teams.
✨Focus on Patient Safety
Emphasise your commitment to patient safety throughout the interview. Discuss how you’ve prioritised this in your work and any initiatives you’ve led to improve quality assurance processes. This will resonate well with the company’s core values.
