Quanticate logo
Quanticate

Biostatistics and Data Experts

PV Consultant Physician

ConsultantConsultantContractRemoteMid LevelTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

2 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

PV Consultant Physician

Quanticate

Role Description Quanticate International is hiring a Pharmacovigilance (PV) Consultant Physician to support clinical and post‑authorisation safety activities for global pharmaceutical and biotech clients. This position provides medical review and specialised input across safety reporting, medical monitoring, and regulatory documentation. You will work within established procedures and quality standards while applying medical judgement across multiple projects. This is a fully remote position but applicants need to be based in the UK and also be happy with zero hour contract. Key Responsibilities - 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. Qualifications - 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. Benefits - Be part of a knowledgeable global team and contribute to important drug safety work. - Varied project exposure and professional growth. - Opportunity to apply clinical expertise within an established CRO environment. - Career development support, including membership to professional societies. - Encouragement of involvement in activities and committees.

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