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- Tasks: Lead pharmacovigilance efforts to ensure patient safety and regulatory compliance.
- Company: Join a global biotech leader transforming lives through innovative gene therapies.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Why this job: Make a real impact in patient safety and contribute to groundbreaking therapies.
- Qualifications: Extensive experience in pharmacovigilance and knowledge of regulatory requirements.
- Other info: Be part of a high-performance team dedicated to innovation and excellence.
The predicted salary is between 72000 - 108000 £ per year.
Location: Boston, MA or London, UK
Reporting to: Vice President, Clinical Development
Job Summary
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety, regulatory compliance, and the meeting of Company objectives. They will ensure the monitoring and communication of the safety of the Company products to both internal and external stakeholders throughout the clinical development to market life cycle. This will be achieved using cost-effective, up to date, globally compliant processes. This is a unique opportunity to join an agile and progressive team who are working to bring innovative therapies to patients.
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:
- Bringing expertise through the writing of clinical development plans, protocols, and study reports, aggregate analyses (PBRERs / DSURs), regulatory submissions (BLA/NDA/MAA dossiers, briefing documents, Risk Management Plans, REMS), and post-marketing commitments.
- Creating detailed reports and evaluations of benefit-risk for internal audiences and external regulatory stakeholders.
- Driving proactive, continuous risk assessment to optimize the benefit-risk profile of all products in the development 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,
- Ensures high-quality Standard Operating Procedures are described within a robust Pharmacovigilance System Master File.
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 and, ideally, PMDA), including relevant GCP/ICH guidelines.
- Proven experience interacting with Regulatory Authorities for IND, NDA, BLA, and MAA submissions.
- Experienced in the implementation of commercial drug safety databases and managing software supporting global Pharmacovigilance operations.
- Gene therapy/ultra rare/orphan diseases background strongly desired.
Head of Pharmacovigilance employer: Orchard Therapeutics
Contact Detail:
Orchard Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Pharmacovigilance
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that might just land you that dream job.
✨Tip Number 2
Prepare for interviews by researching Orchard Therapeutics and their products. Show us you’re passionate about patient safety and innovative therapies. Tailor your answers to reflect how your experience aligns with their mission.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you on their radar and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of our team at Orchard Therapeutics.
We think you need these skills to ace Head of Pharmacovigilance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of Pharmacovigilance role. Highlight your relevant experience in pharmacovigilance leadership and any specific knowledge of regulatory requirements. We want to see how your background aligns with our mission at Orchard Therapeutics!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about patient safety and how your expertise can drive our objectives. Keep it engaging and make sure it reflects your personality – we love authenticity!
Showcase Your Leadership Skills: As a leader, it's crucial to demonstrate your ability to cultivate high-performance teams. Share examples of how you've coached and mentored staff in the past. We’re looking for someone who can inspire and lead our Pharmacovigilance department effectively.
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 see what you bring to the table!
How to prepare for a job interview at Orchard Therapeutics
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge, especially around global regulatory requirements like EMA, MHRA, and FDA. Be ready to discuss how your experience aligns with the responsibilities of the Head of Pharmacovigilance role, particularly in leading safety assessments and managing compliance.
✨Showcase Your Leadership Skills
This role requires strong leadership, so think of examples where you've successfully led a team or project. Prepare to share how you've cultivated high-performance cultures and mentored staff in previous positions. Highlighting your ability to inspire and guide others will set you apart.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. For instance, how would you handle a sudden safety issue with a product? Practise articulating your thought process and decision-making strategies, as this will demonstrate your readiness for the challenges of the role.
✨Connect with Their Mission
Orchard Therapeutics is all about transforming lives through innovative therapies. Show genuine enthusiasm for their mission and be prepared to discuss how your values align with theirs. This connection can make a big difference in how they perceive your fit for the company culture.
