Medical Safety Specialist II
Há 13 horas
We are PrimeVigilance, a leading mid-size pharmacovigilance service provider. Our company has achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
Our team provides first-class support to pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.
We invest in our staff by providing an excellent training and development platform. Employee experience, well-being and mental health are highly valued, and we acknowledge that a healthy work-life balance is essential for employee satisfaction and high-quality client service.
The job involves reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. This includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
You will act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues. Your tasks include reviewing and providing input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
You will also review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings. Additionally, you will cooperate in the preparation of and provide input in Risk Management Plans, supporting the preparation of responses to regulatory authority requests, and signalling.
Other responsibilities include reviewing line listings, participating in signal detection activities, including meetings, writing signal detection reports if applicable, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation. You will evaluate and categorize possible signals and propose a course of action.
As a PV Physician, you should be medically qualified as a physician. Previous experience in pharmacovigilance is required. You must be able to review different aggregate report types, including PBRERs and DSURs. Expertise in signal detection activities is essential.
A strong ability to plan, organise, prioritise and execute multiple tasks is necessary. You must be able to work effectively cross-culturally and cross-functionally, valuing the importance of teamwork. English - advanced (spoken, written) and advanced literacy (MS Office) are required.
Estimated annual salary: £50,000-£70,000 depending on location and experience.
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