Britannia Pharmaceuticals CV

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

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

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

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.

                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

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

In my spare time enjoy Cycling and karting.