Britannia Pharmaceuticals CV

Hayes, Middlesex


  • Britannia Pharmaceuticals



    Personal Details
    Telephone Number:   View Contact Details
    City:   Hayes
    County:   Middlesex
    Desired job title:   Britannia Pharmaceuticals
    Salary:   £40001 - £60000
    Location:   Hayes Middlesex
    Education Level:   Bachelors
    Last Login:   about 8 months ago

    Normal

    More...

    Industries

    Administration Healthcare IT Scientific Pharmaceutical medicine

    Job Titles

    Acupuncturist Graphic Web Designer Clinical Research Nurse Clinical Team Leader Assistant Ecologist Administration Supervisor Pharmacovigilance Officer Senior PV Associate

    Skills

    Suspected Unexpected Serious Adverse Reactions MedDRA Argus Triage safe administration initial evaluation Pharmacovigilance Adverse Events Reconciliations

    Employment History

    Britannia Pharmaceuticals

    2017 - Present

    Britannia Pharmaceuticals Senior PV Associate ------- * Processes and distributes safety reports received from any source (MHRA, Medical Information, Literature sources, and post-marketing) for assigned products and/or studies, as per UK/EU regulatory requirements and company SOPs, policies and procedures. * Perform reconciliations with all service providers, partners, Denzapine monitoring service, medical information and third parties to ensure ICSR compliance is met within timeline as per procedures. * Support PV team for any adhoc ICSR or other PV related requirements e.g SOP writing, training new members, signal detection, Eudravigilance signal detection, tracking updates and implementation of GVP module changes into related PV activities. * Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and perform necessary checks for duplicate cases. * Determines and performs necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and documents accordingly. * When required for maintains administrative systems and processes necessary to meet all regulatory requirements * Conducts weekly literature searches to include detection of adverse events or important safety information relating to relevant products or ordering of articles for partners * Ensures all Company and regulatory timeframes are met for the processing and reporting of safety information Denzapine Monitoring Service * Ensures all enquiries are dealt with in a consistent timely, efficient and accurate manner in line with departmental procedures and guidelines or are forwarded to appropriate personnel in an expedited manner. This includes all enquiries relating to Medical Information and Drug Safety functions. * Receipt and inputting of blood results in


    Senior PV Associate

    2013 - 2016

    * To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews, as required. * To process Individual Case Safety Reports (ICSRs), including literature reports. * To follow-up ICSRs with the reporter, generate FU queries and send FU requests. * To perform ICSR reconciliation with business partners. * To archive all ICSR documentation, according to the SOPs and procedures. * Performing a duplicate check. * Performing triage/quality review of ICSRs * Performing data entry of adverse event case reports onto the safety database (Arisg/Argus) and MedDRA coding. * Processing SAEs and SUSARs. * Performing seriousness assessment. * Performing listedness assessment. * Receiving and returning safety messages and acknowledgements of receipt * Reporting of Individual case Safety Reports (ICSRs) to Regulatory Authorities, Ethics Committees (EC)/Institutional Review Boards (IRB) and Investigators * Exchanging of ICSRs with Clients or Client Partners


    PV Case administrator

    2010 - 2013

    * Maintenance of the central Department of Pharmacovigilance electronic mail box in real-time to ensure ICSRs from clinical and spontaneous sources are passed on for triage and further processing in a timely manner using a system which promotes efficiency * Registering ICSRs into the Pharmacovigilance Database to ensure the timely processing of ICSRs by Pharmacovigilance staff within the department, including compliance with company standard operating and regulatory requirements * Acknowledgement of receipt of cases and other such information * Perform the accurate triage and entry of data pertaining to ICSRs within timelines defined in the Company SOPs and other guidelines and user manuals etc.


    product Coordinator

    2009 - 2010

    Merz Pharma UK ltd Denzapine product Coordinator


    Clinical research technician

    2007 - 2009


    Lab technician

    2006 - 2009


    Education History

    Name of Institution: T.A Marryshow College

    Institute Location: , , , GD

    Education Title: Pharmacy


    Hobbies & Interest

    Hobbies/Interests In my spare time enjoy Cycling and karting.

    Employer Reference



    Personality Assessment data not available!


    Britannia Pharmaceuticals CV Profile

    ####### ########                                                       

    Mobile: 0##########

    Email: ########################                                                                                           

             

    Personal Profile

    A highly motivated and well organised individual with ten years’ experience in a variety of pharmacovigilance/ medical environments. Thrives on providing solid and essential back up to key positions and projects. A calm head and meticulous eye for detail ensures that all duties are carried out to the highest standards and in allotted time frames.  Comfortable working as part of a team or independently with a focus on delivering quality support to manager and team members on a continuous basis.

     

    Key Skills

                    A genuine interest in helping customers

                    A polite, thoughtful and friendly attitude

                    The ability to handle complaints and difficult situations

                    Strong organisational, administrative and general office skills

                    Workload and time management and multi-tasking

                    Broad knowledge and experience of Microsoft Office

                    Dedicated and driven and always on task

                    Confident communicator

                    Attention to detail

     

    Employment history

    Britannia Pharmaceuticals              Senior PV Associate                           Oct-2017 – Jan-2020  

                    Processes and distributes safety reports received from any source (MHRA, Medical Information, Literature sources, and post-marketing) for assigned products and/or studies, as per UK/EU regulatory requirements and company SOPs, policies and procedures.

                    Perform reconciliations with all service providers, partners, Denzapine monitoring service, medical information and third parties to ensure ICSR compliance is met within timeline as per procedures.

                    Support PV team for any adhoc ICSR or other PV related requirements e.g SOP writing, training new members, signal detection, Eudravigilance signal detection, tracking updates and implementation of GVP module changes into related PV activities.

                    Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and perform necessary checks for duplicate cases.

                    Determines and performs necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and documents accordingly.

                    When required for maintains administrative systems and processes necessary to meet all regulatory requirements

                    Conducts weekly literature searches to include detection of adverse events or important safety information relating to relevant products or ordering of articles for partners

                    Ensures all Company and regulatory timeframes are met for the processing and reporting of safety information

     

    Denzapine Monitoring Service

                    Ensures all enquiries are dealt with in a consistent timely, efficient and accurate manner in line with departmental procedures and guidelines or are forwarded to appropriate personnel in an expedited manner. This includes all enquiries relating to Medical Information and Drug Safety functions.

                    Receipt and inputting of blood results in DMS and provision of colour of result.

                    Continuously monitors patient blood results to ensure the appropriate and safe administration of Denzapine, to ensure all abnormal results are reported according to relevant protocols.

                    Liaises closely with central and local laboratories on all aspects relating to patient blood samples and blood results.

                    Adheres to CNRD requirements to ensure patient safety.

                    Answers all incoming calls within 3 rings, in a courteous and customer focussed manner and ensures phone cover is provided during hours of service.

     

    PrimeVigilance Ltd                             Senior PV Associate                         Sep 2013 – April 2016

                    To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews, as required.

                    To process Individual Case Safety Reports (ICSRs), including literature reports.

                    To follow-up ICSRs with the reporter, generate FU queries and send FU requests.

                    To perform ICSR reconciliation with business partners.

                    To archive all ICSR documentation, according to the SOPs and procedures.

                    Performing a duplicate check.

                    Performing triage/quality review of ICSRs

                    Performing data entry of adverse event case reports onto the safety database

    (Arisg/Argus) and MedDRA coding.

                    Processing SAEs and SUSARs.

                    Performing seriousness assessment.

                    Performing listedness assessment.

                    Receiving and returning safety messages and acknowledgements of receipt

                    Reporting of Individual case Safety Reports (ICSRs) to Regulatory Authorities, Ethics Committees (EC)/Institutional Review Boards (IRB) and Investigators

                    Exchanging of ICSRs with Clients or Client Partners

     

    Ipsen Biopharm Ltd          PV Case administrator and DE specialist         Jan 2010 –Sep 2013

                    Maintenance of the central Department of Pharmacovigilance electronic mail box in real-time to ensure ICSRs from clinical and spontaneous sources are passed on for triage and further processing in a timely manner using a system which promotes efficiency

                    Registering ICSRs into the Pharmacovigilance Database to ensure the timely processing of ICSRs by Pharmacovigilance staff within the department, including compliance with company standard operating and regulatory requirements

                    Acknowledgement of receipt of cases and other such information

                    Perform the accurate triage and entry of data pertaining to ICSRs within timelines defined in the Company SOPs and other guidelines and user manuals etc.

     

    Merz Pharma UK ltd             Denzapine product Coordinator                    Dec 2009 – Jan 2010

    Hammersmith Medicines research Ltd   Clinical research technician Sep 2007 – May 2009

    Alcontrol ltd                                         Lab technician                                          April 2006 – Sep 2009

    Education

    Back to basics in Pharmacovigilance

    Drugs Safety Research Unit

    Pharmacy

    T.A Marryshow College (Grenada, West indies)

     

    Hobbies/Interests

    In my spare time enjoy Cycling and karting.

    Enter text here...

    Download CV