Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Senior PV Scientist

Gold Group Ltd
Job LocationCambridgeshire
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Senior PV ScientistCambridgeshireBriefSenior PV Scientist needed for a multinational Pharmaceutical organisation based in Cambridgeshire who are looking to employ an experienced and well-rounded Senior PV Scientist to lead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. The Senior PV Scientist will be required to author and lead PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.Main Responsibilities:

  • Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
  • The Senior PV Scientist will be required to lead PS activities of cross-functional project teams for developmental compounds and/or marketed products.
  • Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
  • Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
  • The Senior PV Scientist will be required to present complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
  • Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
  • Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
  • Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
  • Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
    • Requirements - Education and Experience
  • A Senior PV Scientist will be required to have a life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
  • Fluent in written and verbal English
  • Advanced knowledge of PV regulations
  • Intermediate understanding of epidemiology, preferred
    • This really is a fantastic opportunity for a Senior PV Scientist to progress their career. If you are interested, please apply as soon as possible as this position will be filled quickly so dont miss out!Services advertised by Gold Group are those of an Agency and/or an Employment Business.We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.

    APPLY NOW

    Senior PV Scientist Related Jobs

    © 2019 Naukrijobs All Rights Reserved