Clinical Development Specialist
4 days ago
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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