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- Tasks: Lead pharmacovigilance efforts to ensure patient safety and regulatory compliance.
- Company: Join Orchard Therapeutics, a pioneering biotech company transforming lives through gene therapy.
- Benefits: Competitive salary, career growth opportunities, and a chance to make a real impact.
- Why this job: Be at the forefront of innovative therapies and safeguard patient health globally.
- Qualifications: Extensive experience in pharmacovigilance and knowledge of regulatory requirements.
- Other info: Dynamic environment with a focus on mentorship and high-performance culture.
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.
- 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
Head of Pharmacovigilance 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
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars where you can meet people who might know about openings at Orchard Therapeutics or similar companies.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of pharmacovigilance best practices and regulatory requirements. We recommend creating a list of common interview questions and practising your responses to show off your expertise.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've cultivated high-performance teams in the past. Use specific examples that highlight your ability to mentor and coach staff, as this is crucial for the Head of Pharmacovigilance role.
✨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 and engaged with our company.
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 extensive experience in pharmacovigilance leadership and any relevant regulatory interactions. 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 skills can help us transform lives. Be sure to mention specific experiences that relate to the responsibilities outlined in the job description.
Showcase Your Leadership Skills: As a leader, it's crucial to demonstrate your ability to cultivate a high-performance culture. Share examples of how you've coached and mentored teams in the past. We love seeing candidates who can inspire others and drive results!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Don’t miss out on this opportunity!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge, especially around international regulatory requirements and best practices. Be ready to discuss specific examples from your past experience that demonstrate your expertise in leading pharmacovigilance efforts.
✨Showcase Your Leadership Skills
As the Head of Pharmacovigilance, you'll need to lead a team effectively. Prepare to share your leadership style and how you've successfully coached and mentored staff in previous roles. Think of specific instances where your leadership made a difference.
✨Be Ready for Regulatory Questions
Expect questions about your experience with regulatory submissions like IND, NDA, BLA, and MAA. Have clear examples ready that highlight your interactions with regulatory authorities and how you navigated challenges during these processes.
✨Demonstrate Strategic Thinking
The role requires a strategic approach to product safety. Prepare to discuss how you've developed and executed strategies in past roles, particularly in relation to risk assessment and benefit-risk evaluations. Show them you can think ahead and align with company objectives.