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Quanticate

Biostatistics and Data Experts

PV Consultant Physician – Zero Hour Contract

ConsultantConsultantContractRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

4 days ago

Salary

0

Seniority

Senior

Postgraduate DegreeEnglishGoogle Cloud Platform

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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