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- Tasks: Lead pharmacovigilance to ensure patient safety and regulatory compliance in gene therapy.
- Company: Join Orchard Therapeutics, a pioneering biotech company transforming lives through innovative therapies.
- Benefits: Competitive salary, career growth opportunities, and a chance to make a real impact.
- Why this job: Be at the forefront of gene therapy and shape the future of patient safety.
- Qualifications: Extensive experience in pharmacovigilance and strong leadership skills required.
- Other info: Dynamic environment with a focus on collaboration and innovation.
The predicted salary is between 72000 - 108000 ÂŁ per year.
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases. The Head of Pharmacovigilance will lead pharmacovigilance for Orchard, driving patient safety, regulatory compliance, and the achievement of company objectives across the clinical development to market lifecycle.
Responsibilities
- Leads the development and execution of a strategic, globally aligned approach to product safety across development and post‑marketing, including but not limited to:
- Writing clinical development plans, protocols, and study reports; preparing aggregate analyses (PBRERs / DSURs); submitting regulatory dossiers (BLA/NDA/MAA), briefing documents, Risk Management Plans, REMS, and post‑marketing commitments.
- Creating detailed benefit‑risk reports and evaluations for internal audiences and external regulatory stakeholders.
- Driving proactive, continuous risk assessment to optimize the benefit‑risk profile of all products in the pipeline and on the market.
- Enables real‑time monitoring and benefit‑risk assessment throughout the product lifecycle, including post‑marketing surveillance and post‑approval commitments.
- Meets global regulatory requirements and advances company strategic objectives while safeguarding patient safety.
- Maintains high‑quality Standard Operating Procedures described within a robust Pharmacovigilance System Master File.
Requirements
Experience
- Extensive experience in pharmacovigilance leadership roles in biotech/pharma and/or regulatory agencies.
- Extensive knowledge of pharmacovigilance best practices and international regulatory requirements (EMA, MHRA, FDA, PMDA) and relevant GCP/ICH guidelines.
- Proven experience interacting with regulatory authorities for IND, NDA, BLA, and MAA submissions.
- Experience in implementing commercial drug safety databases and managing software for global pharmacovigilance operations.
- Gene therapy or ultra‑rare/orphan disease background strongly desired.
Skills & Abilities
- Demonstrated ability to develop and implement a global PV strategy and maintain a compliant, inspection‑ready system.
- Skilled in working within matrixed, global organizations and successfully collaborating with international cross‑functional teams.
- Proven leadership in pharmacovigilance with the ability to build high‑performing teams and drive change in dynamic, cross‑cultural environments.
- Strong strategic and operational acumen, able to lead teams while contributing hands‑on.
- Exceptional communication and influencing skills, including confident engagement with regulatory authorities and key stakeholders.
- Decisive, accountable, proactive problem‑solver with strong analytical and organizational skills.
- Collaborative and solution‑oriented mindset with a track record of delivering in fast‑paced, complex settings.
Education
- Medical degree desired, ideally with a relevant postgraduate qualification (e.g., MRCP, MRCS, MFPM, MD).
- Advanced degree holders (PharmD, Ph.D.) will also be considered.
Head of Pharmacovigilance in City of London employer: Orchard Therapeutics - U.S.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Pharmacovigilance in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching Orchard Therapeutics and their approach to pharmacovigilance. Understand their products and recent developments. This will help you tailor your answers and show that you're genuinely interested in the role.
✨Tip Number 3
Practice your pitch! Be ready to explain how your extensive experience aligns with the responsibilities of the Head of Pharmacovigilance. Highlight your leadership skills and how you've driven change in previous roles.
✨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 are proactive about their job search!
We think you need these skills to ace Head of Pharmacovigilance in City of London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Head of Pharmacovigilance role. Highlight your relevant experience in pharmacovigilance leadership and any specific achievements that align with the job description. We want to see how you can bring value to our team!
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use examples from your past roles to illustrate your strategic thinking, leadership abilities, and experience with regulatory authorities. This is your chance to shine, so let us know what you can do!
Be Clear and Concise: When writing your application, keep it clear and to the point. Avoid jargon unless it's industry-specific and relevant. We appreciate straightforward communication, so make sure your passion for patient safety and pharmacovigilance comes through without unnecessary fluff.
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 you’re keen on joining our team at Orchard Therapeutics!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Stuff
Make sure you brush up on pharmacovigilance best practices and international regulatory requirements. Familiarise yourself with the specific guidelines from EMA, MHRA, FDA, and PMDA. This knowledge will not only help you answer questions confidently but also show that you're genuinely interested in the role.
✨Showcase Your Leadership Skills
As the Head of Pharmacovigilance, you'll need to demonstrate your ability to lead and build high-performing teams. Prepare examples of how you've successfully managed teams in the past, especially in dynamic environments. Highlight your coaching and mentoring experiences to show you can cultivate talent.
✨Prepare for Regulatory Discussions
Expect questions about your experience interacting with regulatory authorities. Be ready to discuss specific instances where you've submitted INDs, NDAs, BLAs, or MAAs. This is your chance to showcase your strategic thinking and operational acumen in navigating complex regulatory landscapes.
✨Emphasise Collaboration
Collaboration is key in this role, so be prepared to talk about your experience working within matrixed, global organisations. Share examples of how you've successfully collaborated with cross-functional teams and how you’ve driven change in a multicultural environment. This will highlight your solution-oriented mindset.
