Pharmacovigilance Scientist / Drug Safety Scientist

Job Description

Role Title: Pharmacovigilance ScientistDuration: 12 MonthsLocation: LondonRate: £59 per hour - Umbrella (7.5 hour days)Role purpose / summaryWe are seeking a Pharmacovigilance Scientist for the Safety Evaluation and Risk Management (SERM) team within Global Safety Department, specifically aligned to support products in the ViiV portfolio (HIV). Day-to-day, you will work hands on in monitoring andevaluation of safety profiles to ensure optimal decisions are made with safety in mind. In this role you will be performing routine pharmacovigilance activities such as signal detection/evaluation, authoring key regulatory documents, managing regulatory requestsand more.As a Scientist, you will also play a strategic role, driving discussions and improvements in safety management. You’ll present findings to senior stakeholders and governance bodies and must therefore be comfortable engaging with colleagues at all levels ofthe organisation. This position offers the successful candidate the chance to develop your expertise, and making a significant personal impact on the safety of HIV products. You’ll, you’ll work with a highly skilled and supportive team – a group where individualshelp one another both in their progression and growth, and in their regular activities.Key Responsibilities include, but are not limited to:• Assisting with the monitoring and evaluation of safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle• Conducting routine pharmacovigilance activities(knowledge of the CommonWealth Vigilance Workbench would be advantageous, literature review and, in partnership with safety physician, tools for individual case awareness for all products in area of responsibility),signal detection/evaluation and leading authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs)• Ensuring that all safety documentation is accurate and available to meet global compliance and regulatory requirements• Driving discussions and the management of safety issues within the wider safety team• Leading presentation of safety-related findings to senior stakeholders (including Vice President and Senior Leadership Teams) and to ViiV’s governance bodies#Key Skills/ requirementsThis role is within the Global Safety Department and you will need to be highly self-motivated with a true passion for pharmacovigilance. You will also be resilient and calm under pressure, with strong interpersonal skills, and a continuous improvement mindset.You will be comfortable working with complex matrix organisation, as you will frequently collaborate with safety staff and other groups outside of safety, including leaders throughout ViiV’s R&D division. We need someone in this role who is comfortable workingat pace and who can deal with change.All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!• Bachelors, or above, degree in Biomedical or Health Care related speciality• Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation• Competent medical/scientific writing skills• Sound computing skills Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.• Knowledge and experiencee of the principles of causality assessment and the evaluation of safety signals• Basic understanding of the HIV therapy area would be an advantage• Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology)• Basic knowledge of medical and drug terminology• Basic understanding of drug development process• Basic understanding of drug approval process in major countries