Senior PV Scientist

Senior PV Scientist

Cambridgeshire

Brief

Senior 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 don't miss out!

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