Senior Pharmacovigilance Manager

5 days ago

Hertfordshire, United Kingdom Quanta part of QCS Staffing Full time

Senior Pharmacovigilance Manager – Biopharmaceuticals - Hertfordshire / Remote Our client, a global biopharmaceutical company with plants across Europe and North America is looking for a Senior Pharmacovigilance Manager to join their team in the UK. This is your chance to be part of one of the top players in the field of plasma-derived products, supplying high-quality medicines treating rare diseases, across the globe. Essential Duties and Responsibilities for this Senior Pharmacovigilance Manager role include, but are not limited to, the following: Responsible for the management of case-processing activities through all phases of development, to properly address any ADRs/Special Situations possibly associated to medicinal products licensed/distributed by our client. and its subsidiaries. Ensures proper management of worldwide/national literature research in order to detect meaningful safety data. Ensures correct handling of data reconciliation activities with all the internal supportive functions as defined by Company procedures. Ensures proper management of Aggregate Reports (PSURs, PAERs, RMPs, AdCOs) of medicinal products licensed/distributed by our client and its subsidiaries. Ensures the compilation, update, review of Dossier and Printouts (SPC/PI) for the parts pertaining to Pharmacovigilance, in collaboration with the Global Regulatory Affairs department. Ensure support to the Clinical Research Department in drafting the Safety Study Plan (SSP), in the correct management of ADRs/ICSRs from clinical studies/trials, in drafting the Investigator's brochure (IB) and the Development Safety Update Reports (DSUR). Ensures management of Reference Safety Information over time.  Support both the EU QPPV and the PV Medical Unit, in all phases of the signal management process, from their detection to their communication, including the management of the identified actions. Collaborate with the corporate departments involved in the management of Post Authorization Safety Studies and the Patient Support Program, from the review of protocols/reports to the training of the personnel involved and the analysis of the data collected. Maintain awareness and ensure adherence to established and updated local and global processes as well as national and international regulations and guidelines for activities linked with his/her scope. Desirable Experience: Master’s degree in life sciences field 8+ years of experience drug safety and pharmacovigilance in the pharmaceutical industry Experience in participating in Audits and Inspections Experience with use of safety databases, preferably Veeva Vault Knowledge of UK, FDA, EU, and international adverse event reporting regulations per ICH guidelines and ability to interpret and apply applicable regulations to resolve issues. Experience in the management of Aggregate Reports (PSUR/PAER/RMP). Demonstrated competence in obtaining, analysing, disseminating and reporting safety information in compliance with global regulations Experience with the preparation of investigational regulatory reports Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook) If this role is of interest, please apply now. #LI-KT1

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