Otilia Elena Hurezanu

Experience

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  Farmaciile DONA

  Sept 2011 - May 2013

  • Pharmacist

    Sept 2012 - May 2013

  • Junior Pharmacist

    Sept 2011 - Sept 2012
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  Floreasca Emergency University Hospital ,Bucharest

  Jan 2013 - Jan 2016

  Clinical Pharmacist Resident
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  Allergan, formerly Actavis

  May 2013 - Aug 2016

  Pharmacovigilance specialist

  Resposabilities:• Data entry of ICSRs of marketed products in ARGUS safety database• Review of literature cases, MedDRA coding, QC control of ICSRs• SOPs writing • Training and mentoring of the PV members staff• Signal detection.

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  Teva Pharmaceuticals

  Aug 2016 - Mar 2017

  Pharmacovigilance Scientist, Medical Scientific Unit

  Responsabilities:• Retrieve and analyze data to assist review and evaluation of safety information post marketing products• Respond to Authority enquires on PV related matters with appropriate data, within the established timeframes• Assessment of clinical implications and health hazards associated with quality issues of products• Data entry and quality review of ICSRs.

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  Bausch Health Companies Inc.

  Mar 2017 - Jan 2019

  Responsabilities:• Oversee the proper and timely collection and reporting of AE information• Review and approve AE/SAE reports for pre and post marketed products: clarify medical issues, insure clear narratives, revise MedDRA terms and coordinate with external vendor and internal medical personnel as needed• Review of clinical trial protocols (Phase I-III) , develop Safety Management Plans, assist with creation of Analysis of similar events and Investigator Notification letters for IND Safety reports generated from Company sponsored clinical trials• Analyze metrics for critical processes to ensure high quality and compliance with regulatory requirements and Company SOPs• Act as representative for local PV personnel issues and escalate any problems to the applicable relevant party either at local country office or Global PV Department. Show less Responsabilitites:• Intake and forwarding of Adverse Events (concerning medicinal products, cosmetics, biocides, nutritionals - as applicable) to GPRM or partner (as applicable); documentation and tracking of AEs; reconciliation activities and documentation; Perform follow-up activities as applicable and document• Forward AEs for Medical Devices from EMEA to Legal Manufacturers in EMEA or to contact person for manufacturers outside EMEA according to respective written procedures • Support Direct Healthcare Professional Communication, additional risk minimization measures and other risk minimization measure activities according to RMP (in cooperation with Risk Management Group and partner, if applicable)• Perform/organize local literature search; documentation of local literature search• Organize PV training for local affiliate employees including sales representatives, and distributors as applicable• Check for changes in local regulatory environment and inform upper GPRM management incl. EU QPPV in case of relevant new safety information• Inform upper GPRM management (incl. EU QPPV) regarding changes in local responsible persons• Communicate any urgent safety issues to upper GPRM management (incl. EU QPPV).• Ensure update of PV related local SOPs on a regular basis or if required• Support review of local SDEAs and compliance (especially with local PV contractors) in cooperation with global SDEA team• Act as local contact point for audits and inspections and related processes .Supervisory resposabilities: Deputy LPM Show less

  • PV Manager, Global Pharmacovigilance and Risk Management

    May 2018 - Jan 2019

  • Local Pharmacovigilance Manager

    Dec 2017 - Jan 2019

  • Pharmacovigilance Specialist, Global Pharmacovigilance and Risk Management

    Mar 2017 - May 2018
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  Allergan

  Jan 2019 - May 2020

  Senior Manager, Patient Safety Operations,Global Patient Safety & Epidemiology

  Responsibilities:• Oversee the collection, preparation, processing, follow-up activities, submission and reporting of Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations• Support the PV Director, provide back-up as needed and collaborate to establish departmental procedures, ensure assignments are completed in timely manner and resolutions of any case processing issue ensuring escalation of issues when needed• Ensure on-going training and mentoring of the PV staff members• Maintain current best practices, and support the implementation of changes in global pharmacovigilance regulations and guidelines for marketed and investigational products• Represent and support PV in relevant global initiatives, safety monitoring activities, PV Quality Management System, audits and inspections• Provide support and oversight of clinical development activities to include clinical team meetings, authoring of Safety Management Plans (SMP), SUSAR processing and submissions, investigator notifications and reconciliation activities for Allergan sponsored studies• Serve as point of contact between Market Research project managers, vendors and strategic partners for all Allergan operational issues as assigned• Assign tasks and manage workload for members of assigned therapeutic area.Supervisory responsibilities: Sr./PV Specialists, PV Analysts, PV Administrators. Show less

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  AbbVie

  May 2020 - now

  • Senior Manager, Pharmacovigilance & Patient Safety, Epidemiology, R&D Quality Assurance, Data Office

    Jun 2023 - now

  • Senior Manager, Pharmacovigilance & Patient Safety, PV Systems

    Jul 2021 - Jun 2023

  • Senior Manager, Pharmacovigilance & Patient Safety, PV Operations

    May 2020 - Jul 2021