Senior Pharmacovigilance Specialist

2 weeks ago

London, Greater London, United Kingdom Orchard Therapeutics Full time

**Job Summary:**

We are seeking a highly skilled Senior Pharmacovigilance Specialist to join our team at Orchard Therapeutics.

About the Role:

This is an exciting opportunity for a motivated and experienced professional to work in a dynamic environment, supporting the Head of Pharmacovigilance and the Clinical Science team. The successful candidate will be responsible for ensuring the safety of our products throughout their life cycle, complying with international regulatory requirements, and contributing to the company's objectives.

Main Responsibilities:

  1. Contribute to the preparation of high-quality scientific data for safety evaluations of our products, ensuring timely delivery and accurate interpretation of results.
  2. Prepare aggregate reports and responses to Regulatory Agency requests, including analysis and data preparation.
  3. Provide safety components for marketing authorization applications (MAA, BLA, and NDA).
  4. Maintain awareness of regulatory guidance documents, changes, and best practices in pharmacovigilance, making recommendations to improve department effectiveness.
  5. Support the maintenance of our global safety database, updating allocated Standard Operating Procedures (SOPs), guidelines, and User Manuals.
  6. Contribute to training courses for external and internal staff, enhancing knowledge sharing and capacity building.

Key Requirements:

  • Bachelor's degree in Pharmacy, Medical Sciences, Biological Sciences, or a related health profession, with at least 2 years of experience in a Pharmacovigilance Department.
  • Excellent written and verbal communication skills, with the ability to produce high-quality work under pressure.
  • Strong time management, teamwork, and interpersonal skills, with fluency in English.
  • Working knowledge of regulatory requirements for pharmacovigilance, particularly in pre- and post-approval environments.
  • Experience with Drug Safety Databases, MedDRA coding, and Microsoft Office applications.

What We Offer:

  • A competitive salary of approximately $120,000 per year, commensurate with experience.
  • An opportunity to work in a dynamic and innovative company, driving patient safety and compliance.
  • Ongoing professional development and training to enhance skills and knowledge.

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