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Saclay

    Safety International Project Lead - Saclay, France - Servier

    Servier
    Servier Saclay, France

    il y a 2 semaines

    Default job background
    CDI
    Description

    .

    The Safety International Project Lead is mainly responsible for the management of the following processes under the supervision of the Director Global Patient Safety International unit & EEA QPPV Office:

    Managing the process for PV Regulatory intelligence

    Managing the activity related to the PV agreements established with the commercial partners of Servier group (Licensing In and Out)

    Participating in the coordination of the network of local PV managers in order to ensure the implementation of a local PV system in compliance with corporate procedures and PV regulatory requirements.

    Participates in the functioning of the EU QPPV office by ensuring that the EU QPPV has a global vision of the Pharmacovigilance system as required by European regulations.

    Specific Activities & Responsibilities

    International PV Regulatory Intelligence:
    - Setting-up a process for Regulatory intelligence and its impact analysis.
    - Coordination and Maintenance of country sheets (including an optimization of the current process and an update of the format of the country files)
    - Performing impact analysis of PV documents received from pharmaceutical industries associations, communication to the dedicated unit at the Global Safety (GS) if applicable
    - Participation in the international PV working group of industry associations
    - Performing Impact analysis of regulatory PV texts transmitted by Regulatory intelligence vendor
    - Tracking all regulatory impacts in terms of PV and their implementation at the level of the global PV system
    - Coordinating with the involved GS unit any draft regulatory texts published by the authorities or transmitted by associations (at corporate and international level) for comments
    - Keeping the Regulatory intelligence tool up to date and analyzing alerts in collaboration with affiliates or business partners
    - Creation and maintenance of quality documents related to this Regulatory intelligence activity
    - Monitoring and impact analysis of regulatory texts in Europe and outside Europe related to the signal detection activities in liaison with the B/R Unit

    PV Business Partnership management
    - Setting up vigilance agreements, in accordance with the business agreements to which they relate to and negotiate them with partner companies.
    - Managing the updates of these PV agreements taking into account the substantial changes in related business agreements, products requirements and current PV regulations.
    - Ensuring the validation of the PV clause present in the Business Agreements.
    - Ensuring efficient transversal collaboration with the businesses concerned within the group by setting up new partnerships (Business Development, marketing, legal, pharmaceutical, medical, etc.)
    - Contributing to the management of PV agreements within the dedicated tool.
    - Providing expertise to GS team in connection with the activity of managing PV agreements and contribute to their training on the impact of the activity relating to these agreements on the various businesses.
    - Ensuring the diffusion of PV agreements to the concerned stakeholders
    - Managing the filing and archiving of activity data
    - Providing support to local affiliates during the negotiation of local PVA/SDEAs.
    - Contributing to the establishment and updating of template and procedure for the management of PV agreements in accordance with operational changes affecting this activity and changes in regulations.
    - Providing training for the businesses concerned within and outside the GS department in this procedure and more generally in the PV agreements activity and its impact on the various businesses.
    - Ensuring the close monitoring of the vendor to guaranty his performance

    International PVs coordination & EEA QPPV Office
    - Participating in the implementation of a local PV system at affiliate level: put in place tools for monitoring the activities of LPVs at affiliate level.
    - Based on the data provided by the LPV or business partners, analyzing the impact of local PV regulatory requirements on local and corporate PVs processes in all countries where Servier products are authorized/distributed.
    - Participating in the management of the local QPPV network.
    - Organizing both periodic meetings gathering either the LPVs network or the Local QPPV network.
    - Coordinating the process of managing service contracts impacting PV activities (contracts applying to corporate and subsidiaries) in order to ensure compliance with PVs regulations.
    - Participating in monitoring "compassionate use" at international level in terms of compliance with pharmacovigilance regulations
    - Monitoring deviations and CAPAs of audits and inspections when the International unit and EU QPPV Office is involved.
    - Monitoring additional Pharmacovigilance risk minimization tools implementation follow-up process.
    - Maintaining the global website tracking so as to ensure the reporting of PV case are secured.
    - Providing a support on the business partnership management related to PV activities.
    - Participating in the documentation of the pharmacovigilance system oversight by the EU QPPV.
    - Coordinating the preparation of the Pharmacovigilance System Master File (PSMF)in accordance with the assigned schedule and ensure that its content is complete by liaising with key stakeholders.
    - Providing a support to the LPV who have a regulatory requirement to maintain a local PSMF.
    - Contributing in the training courses (initial and continuous) of subsidiaries and distributors on PVs procedures and activities.
    - Collecting indicators and consolidates data for feedback to EEA QPPV on local PV system.
    - Participating in cross-functional working groups.

    General responsabilitiies


    • Create and maintain quality documents related to scope of activities and ensure they are in line with the regulatory requirements.

    • Periodically report on her/his scope of activities to the direct line manager.

    • Identify potential risks in terms of organisation and needs. Propose solutions and corrective and preventive actions when needed.

    • Participate in audits and PV inspections preparation.

    • Contribute to preparing and monitoring inspections and audits by business partners on a Global Safety departmental level and in the regions allocated to her/his unit.

    • In the event of absence, provide back-up to the International GS Project Managers in her/his scope of activities or to the Director GS International unit.

    Profile

  • Scientific degree (physician, pharmacist, biologist, Master of Sciences)
  • At least 8 years of experience within the pharmaceutical industry in the PV field and in an international environment at a Global level.
  • Excellent knowledge of regulatory requirements at the worldwide level
  • Expertise in setting up a Global and local PV system in compliance with the regulatory requirements
  • Ability to represent the international unit and the EEA QPPV Office during audits and Inspections
  • Experience in challenges linked to managing an international network.
  • Capacity to solve problems encountered by affiliates.
  • Demonstrated ability to supervise large group of people at the international level
  • Cross-cultural awareness, demonstrated ability to work in multinational environment
  • Fluency in English.
  • Good IT experience: pack office and internal tool

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