Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead pharmacovigilance to ensure patient safety and regulatory compliance in gene therapy.
- Company: Orchard Therapeutics, a pioneering biotechnology company focused on rare diseases.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Why this job: Make a real difference in patients' lives while shaping the future of gene therapy.
- Qualifications: Extensive experience in pharmacovigilance leadership and knowledge of regulatory requirements.
- Other info: Join a high-performance team dedicated to innovation and patient safety.
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 postâmarketing, 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 postâmarketing commitments.
- Creating detailed benefitârisk reports and evaluations for internal audiences and external regulatory stakeholders.
- Driving proactive, continuous risk assessment to optimize the benefitârisk profile of all products in the pipeline and on the market.
- Enables realâtime monitoring and benefitârisk assessment throughout the product lifecycle, including postâmarketing surveillance and postâapproval commitments.
- Meets global regulatory requirements and advances company strategic objectives while safeguarding patient safety.
- Maintains highâquality 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 ultraârare/orphan disease background strongly desired.
Skills & Abilities
- Demonstrated ability to develop and implement a global PV strategy and maintain a compliant, inspectionâready system.
- Skilled in working within matrixed, global organizations and successfully collaborating with international crossâfunctional teams.
- Proven leadership in pharmacovigilance with the ability to build highâperforming teams and drive change in dynamic, crossâcultural environments.
- Strong strategic and operational acumen, able to lead teams while contributing handsâon.
- Exceptional communication and influencing skills, including confident engagement with regulatory authorities and key stakeholders.
- Decisive, accountable, proactive problemâsolver with strong analytical and organizational skills.
- Collaborative and solutionâoriented mindset with a track record of delivering in fastâpaced, 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 London employer: Orchard Therapeutics - U.S.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Head of Pharmacovigilance in London
â¨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
â¨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and recent news. This will help us tailor your answers and show that you're genuinely interested in the role.
â¨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. The more comfortable you are speaking about your experience and skills, the better you'll perform when it counts.
â¨Tip Number 4
Don't forget to apply through our website! Itâs the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Head of Pharmacovigilance in London
Some tips for your application đŤĄ
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 knowledge of gene therapy or orphan diseases. We want to see how you fit into our mission!
Showcase Your Skills: Donât just list your skills; demonstrate them! Use examples from your past roles where you've successfully led teams, managed regulatory submissions, or developed safety strategies. This helps us see your potential impact at Orchard Therapeutics.
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 that gets to the heart of your qualifications and experiences.
Apply Through Our Website: We encourage you to apply directly through our website. Itâs the best way for us to receive your application and ensures youâre considered for the role. Plus, it shows your enthusiasm for joining our team!
How to prepare for a job interview at Orchard Therapeutics - U.S.
â¨Know Your Stuff
Make sure you brush up on pharmacovigilance best practices and international regulatory requirements. Familiarise yourself with the latest guidelines from EMA, MHRA, FDA, and PMDA. This knowledge will not only help you answer questions confidently but also show your genuine interest in the role.
â¨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in previous roles. Think about specific situations where you drove change or improved processes. Highlighting your ability to cultivate a high-performance culture will resonate well with the interviewers.
â¨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges in pharmacovigilance. Prepare to discuss your approach to risk assessment and how you would ensure compliance during regulatory inspections. Practising these scenarios can help you articulate your thought process clearly.
â¨Engage with the Interviewers
Donât forget that interviews are a two-way street! Prepare thoughtful questions about Orchard Therapeutics' vision for pharmacovigilance and how they align with patient safety. This shows your enthusiasm for the role and helps you gauge if the company is the right fit for you.
