PV Consultant Physician

Job not on LinkedIn

November 17

Apply Now

Receive Emails with Similar Jobs

Quanticate

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Healthcare Insurance

Quanticate is a leading global biometric Contract Research Organisation (CRO) specializing in clinical data analysis for the pharma and biotech industries. They provide a range of services focused on enhancing clinical trial efficiency and success, including biostatistics, clinical data management, medical writing, and pharmacovigilance. Quanticate leverages advanced methodologies, such as Bayesian approaches, to optimize trial execution and data standardization, ensuring compliance with regulatory standards. They offer scalable resources tailored to client needs and have expertise across various therapeutic areas and trial phases, from early Phase I to post-marketing Phase IV trials. Quanticate is known for its robust data automation, visualisation, and analytics capabilities, which support decision-making and regulatory submissions.

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🎯 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.