Biostatistics and Data Experts
PV Consultant Physician – Zero Hour Contract
Location
United Kingdom
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
PV Consultant Physician – Zero Hour Contract
Quanticate
• Review and assess individual case safety reports, including medical accuracy checks, narrative review, coding verification, assessment and provision of medical causality comments. • Support signal detection activities through regular review of aggregate data. • Provide medical input into periodic safety reports such as DSURs and PSURs. • Review and contribute to project‑specific Safety Plans and other pharmacovigilance (PV) documents. • Provide medical consultancy for pre‑ and post‑marketing activities including study design, protocols, investigator brochures, core safety information and risk management plans. • Support medical monitoring across clinical studies, including review of study documents, training of project teams and contributions to regulatory and ethics submissions. • Attend investigator meetings and Data Monitoring Committee meetings when required. • Provide ongoing medical data review covering adverse events, laboratory results and physical examinations. • Offer guidance to investigators and study teams, including emergency unblinding for safety concerns when necessary. • Provide 24/7 medical contact as required and liaise directly with sponsor teams.
Job Requirements
- Medical Doctor qualification.
- Experience in clinical practice and medical monitoring.
- Strong background in pharmacovigilance, including ICSR triage, medical review and aggregate reporting.
- Clear communication skills with the ability to explain clinical reasoning.
- Strong organisational skills, attention to detail and comfort working to tight timelines.
- Good understanding of ICH GCP and relevant safety regulations.
- Proficient in Word, Excel and standard PC tools.
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