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Специалист по фармаконадзору/ Pharmacovigilance Specialist

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Moscow, Moscow

  1. Исследования и разработки
  2. Фармаконадзор
R00103308

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Описание компании

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn


Описание вакансии

Responsibilities:

Leadership and management

  • Establish and maintain the functioning of the process in the local level in which he/she is a leader;
  • Maintain a continuous improvement environment to optimize the PV partner system and contribute to regional and global process improvement initiatives by working with PPS subject matter experts.

Ensuring the pharmacovigilance system

  • Ensure affiliate PV compliance and actively performs activities to keep the PV system operational;
  • Report compliance issues and potential PV resource issues to the affiliate PV manager in a timely manner to ensure appropriate mitigation;
  • Maintain awareness and monitor local legislation on post-marketing and clinical pharmacovigilance to ensure that changes to PV legislation are brought to the attention of relevant stakeholders, and actively participate in review, impact assessment, implementation and mitigation in accordance with global procedures;
  • Has access to the National AbbVie PV Master File (EAEU PSMF) with the authority to ensure that the information contained is an accurate and up-to-date representation of the PV system.

Quality Management System

  • Contribute to ensuring that the PV partner system procedure(s) is consistent with corporate PV procedures and complies with local and regional PV regulations;
  • Identify and eliminate any nonconformities and/or planned deviations from corporate and/or local PV procedures in accordance with the global issue and exception management process and take any corrective/preventive action in accordance with a previously approved schedule;
  • Ensure the implementation of the PV training plan and ensure affiliate training is in line with corporate and local PV training requirements;
  • Supervise and ensure that the partner company's staff training is in accordance with the requirements of the local contract;
  • Immediately notify Quality Team of any quality complaints associated with the AbbVie products within the appropriate time frame specified in the AbbVie SOP.

Adverse Event & Periodic Safety Reporting

  • Ensure that processes, procedures and systems are in place and regularly implemented in a timely manner to receive, process, conduct follow-up, translate and reconcile adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies;
  • Ensure timely and appropriate submission of both clinical and post-marketing case safety reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators in accordance with PV corporate procedures and local and regional PV regulations as required.

Partnership with business partner with possibility for identification and/or handling of safety information

  • Collaborate with Program Owners and commercial leaders and carry out appropriate pharmacovigilance activities to ensure that all business partnerships associated with activities in which there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.

Safety Data Exchange Agreements (SDEA) and other PV Agreements

  • Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database;
  • Maintain and monitor compliance with local agreements.

Audits and Inspections

  • Actively facilitate and carry out appropriate activities for both internal PV audits and Regulatory Agency PV inspections;
  • Ensure that any audit/inspection responses/corrective actions are completed according to the schedule;
  • Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.

Risk Management within Russia and CIS countries

  • Regularly and timely perform processes and procedures to evaluate new Risk Management Plans (RMPs) or new versions of previously approved RMPs, implement risk mitigation measures in the affiliate in accordance with AbbVie's procedures and local requirements;
  • Be aware of locally applicable RMPs and benefit/risk profile information of products applicable to the Affiliate;
  • As appropriate, participate in the process of proper development and revision of local RMPs and/or country-specific Annexes, if applicable, by liaising with the ARMT and Benefit Risk Management (BRM) Team during the development and revision of local documents;
  • Collaborate with the ARMT and Risk Management (BRM) team during the development or revision of the Local Implementation Plan (LIP) and local additional risk mitigation measures, if needed.

Safety Monitoring

  • Provide a timely review of drug safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency;
  • Understand and monitor incoming local safety data and communicate changes or potential concerns to the affiliate PV Manager for evaluation;
  • Participate in the procedure for preparing and providing a complete and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.

After Hours Availability & Business Continuity

  • Participate in ensuring availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis as required by PV manager;
  • As appropriate, participate in the implementation of a Disaster Recovery Plan/Business Continuity Plan to ensure that critical business processes for the PV continue.

Требования к квалификации

  • Medical, pharmacy or life-sciences degree (or equivalent);
  • At least 2 years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required;
  • Upper-intermediate English level;
  • Adequate theoretical knowledge and practical experience of PV activities and system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV monitoring requirements for assigned territory(ies) that comply with any specific training requirements mandated by relevant regulatory agencies;
  • Excellent written and spoken communication and presentation skills;
  • High customer orientation;
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity;
  • Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

Дополнительная информация

Key Stakeholders:

  • Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel;
  • Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information;
  • National Regulatory Agency responsible for product safety;
  • Pharmacovigilance and Patient Safety, including but not limited to IPEx, Area PV Product Lead, Benefit-Risk Management and QPPV Office;
  • Healthcare Practitioners, consumers and patients.

AbbVie обязуется действовать честно, способствовать инновациям, преобразовывать жизнь людей, служить нашему обществу и поддерживать разнообразие и инклюзивность. Политика AbbVie заключается в приеме на работу квалифицированных специалистов с наибольшими способностями без дискриминации в отношении любого сотрудника или соискателя на работу по признаку расы, цвета кожи, религии, национального происхождения, возраста, пола (включая беременность), физической или умственной неполноценности, состояния здоровья, генетической информации, гендерной идентичности или самовыражения, сексуальной ориентации, семейного положения, статуса защищенного ветерана или любого другого юридически защищенного группового статуса.