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Senior Pharmacovigilance Scientist - SARB

Hays Specialist Recruitment Limited
Job LocationLondon
EducationNot Mentioned
Salary55.00 - 70.00 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time Work from home

Job Description

*Senior Pharmacovigilance Scientist - Aggregate reports, signal & Risk management -Top Pharma - 12m contract* My client is a Global Biopharmaceutical company and they have a position available for a Senior Pharmacovigilance Safety Scientist for an initial 12 - month contract. This contract is Inscope of IR35 and offers homebased working within the UK.Within this role the Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders,reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.Main Responsibilities:

  • Leads Aggregate Report management, including strategy, review and finalisation of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans(RMPs)
  • Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilanceactivities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
  • Leads process for responding to safety questions from regulatory authorities
  • Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests andother product activities, as assigned
  • Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions
In order to apply for the Senior Pharmacovigilance Safety Scientist contract, you should possess extensive experience in the field of pharmacovigilance within the Pharmaceutical industry, including experience in writing aggregate safety reports (PBRERs, PSURs,DSURs, PADERs, Risk Management Plans) and experience in signal detection, management and evaluation. You should possess a strong background in clinical trial drug safety and be able to understand, interpret, analyse, and clearly present scientific and medicaldata in verbal and written format.Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK. This role can be remote working based in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .

Keyskills :
PharmacovigilanceRisk ManagementPSURscontracthomebasedhybridDSURssignal detectionsignal managementAggregate reportsRMPsPBRERsPADERssignalevaluation

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