PV Consultant Physician - Zero Hour Contract

6 days, 14 hours ago
Contract
Senior
Operations
Quanticate

Quanticate

Quanticate is a leading global Clinical Research Organization (CRO) that specializes in the management, analysis, and reporting of clinical trial data, offering comprehensive services such as statistical analysis, data capture, and pharmacovigilance to...

Health Care Providers & Services
251-1K
Founded 1994

Description

  • Review and assess individual case safety reports, including medical accuracy checks, narrative review, coding verification, and causality comments.
  • Support signal detection activities through regular review of aggregate safety data.
  • Provide medical input into periodic safety reports such as DSURs and PSURs.
  • Review and contribute to project-specific Safety Plans and other pharmacovigilance 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.

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.
  • Must be based in the UK.
  • Must be willing to work on a zero-hour contract.

Benefits

  • Fully remote working arrangement.
  • Opportunity to work with global pharmaceutical and biotech clients.
  • Varied project exposure across clinical and post-authorisation safety work.
  • Professional growth within an established CRO environment.
  • Membership to professional societies.
  • Support and encouragement to participate in professional society activities and committees.

Interested in this position?

Apply directly on the company website

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