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.
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.
You will be part of a knowledgeable global team and contribute to important drug safety work. The role offers varied project exposure, professional growth and the opportunity to apply clinical expertise within an established CRO environment.
Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
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.
ABOUT QUANTICATE Quanticate was formed in 2007 from the merger of two specialist Biometrics CROs and is now one of the world’s largest CROs specialising in the provision of clinical data-related services. For almost 3 decades, we have supported pharmaceutical, biotechnology, nutritional and medical device companies in all phases of development and across many therapeutic areas. We are headquartered in Hitchin, in the UK, and have further offices in the UK in Manchester and many leading experts in their fields, based across UK, Europe, America, India, and South Africa. All our employees work as part of global teams and so you will experience international interaction on a daily basis. OUR VISION To be seen as a leading data focused CRO that provides value to its customers through an industry leading customer experience and the provision of expert data solutions that meet current and future development needs. OUR MISSION Our mission is to ensure bespoke quality data is provided to our clients to help bring new medicines to the people who need it. OUR VALUES QUALITY FIRST Delivering exceptional quality at all times is a principal cornerstone of our business. WE CARE We value all relationships and demonstrate respectful behaviour through listening and acknowledging others. ACT WITH INTEGRITY We always act with integrity and work hard to earn and maintain trust in the relationships that we build with our colleagues, customers, and stakeholders. ALL ABOUT PEOPLE Our people are at the centre of everything we do. Their development and wellbeing are our priority; for the people we care for, the people we work for and the people who work for us. COMMITTED TO DELIVER We are committed to deliver results on time, be responsive and adaptable to different requirements. INSPIRE & BE INSPIRED We do our best today to do even better tomorrow. We continuously maintain and encourage a growth mindset.AWARD WINNING COMPANYOur reputation on the market is award winning and we actively work with our employees to provide the kind of experience that makes them want to take their career journey with Quanticate. We offer flexible and friendly working conditions, competitive pay, industry leading benefits, opportunities for international placements and an environment where you are mixing with the very best experts in the field.Our employees are our most important assets, and we support them to offer the best in customer excellence and to enable them to provide value and expertise to our clients.WORK WITH USSo, come and join one of the fastest growing, exciting, innovative, quality focused global CRO’s and see how we can help you get to where you want to be. We want our employees to love working at Quanticate and we want you to be one of them.
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