Clinical Development Specialist

4 days ago


London, Greater London, United Kingdom GlaxoSmithKline Full time

Job Title: Clinical Development Specialist

Location: London, UK

Estimated Salary: £80,000 - £110,000 per annum

Job Description:

We are seeking an experienced Clinical Development Specialist to join our team at GlaxoSmithKline. As a key member of our clinical development team, you will be responsible for ensuring that our products are developed and marketed safely.

Key Responsibilities:

  • Responsible for signal detection and evaluation activities for assigned products
  • Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory periodic reports (in partnership with the product physician)
  • Author the SERM safety contribution to global regulatory submissions in partnership with the product physician
  • May respond to auditors/inspectors' requests for information and completes corrective and preventative actions (CAPAs) within agreed timelines
  • Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation
  • Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed
  • Identify, evaluate, and recommend solutions to problems

About You:

  • Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications
  • Substantial experience in pharmacovigilance or drug development
  • Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
  • Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes
  • Experience working in large matrix organizations


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