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    Countries and Regions PV Manager - Basel, Schweiz - Sobi

    Sobi
    Sobi Basel, Schweiz

    vor 2 Wochen

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    Ganztags
    Beschreibung

    Job Description

    This position plays a crucial role in supporting the efficient delivery of Sobi pharmacovigilance across Sobi countries and regions.

    Reporting to the Head of Countries & Regions, QPPV and closely collaborating with the Countries & Regions team, the Countries and Regions PV Manager is a vital member of the GPV organization focusing on:

    • The Sobi GPV outreach strategy to Sobi country and regional PV, developing, supporting, and driving excellence in post-approval pharmacovigilance activities related to Sobi and its partner products, to ensure local compliance with Sobi/Partner PV system requirements.
    • Providing input to Sobi's geo-expansion activities, to ensure timely implementation of a robust, compliant, and efficient PV system for new products and new markets.
    • Interacting with vendors contracted to carry out local and regional PV activities to enhance local Pharmacovigilance (PV) performance, ensuring compliant, effective, efficient, and business-appropriate standards and processes, and supporting oversight and audit/inspection readiness.
    • Facilitating and communicating PV-related activities and projects between GPV and local teams.

    Key Responsibilities:

    • Contributing to the effective business interface between Sobi GPV and strategic vendors for Sobi local and regional PV activities, including overseeing vendor compliance in assigned countries.
    • Working closely with Sobi global function stakeholders and local Sobi teams to ensure effective communication, collaboration, and issue resolution.
    • Being the point of contact for GPV and other teams for assigned countries.
    • Promoting and implementing continuous improvement activities across all areas related to countries and regions PV activities to optimize quality and productivity, including process improvement and CAPA management and implementation.
    • Working closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures.
    • Being the primary GPV point of contact for local teams for Pharmacovigilance aspects in assigned countries.
    • Ensuring strong relationships with country PV staff to maximize opportunities for Pharmacovigilance, Sobi/partner products, and patients.
    • Identifying, assessing, and escalating risks related to country pharmacovigilance activities to the Head of Countries & Regions, QPPV, and other teams as appropriate, and contributing to implementing actions to address identified risks.
    • Ensuring compliance with processes for quality oversight of local PV activities, including outsourcing activities, review of local PV-related Standard Operations Procedures (SOPs), training, and implementation of PV-related SOPs and procedures, local literature review, aRMM, and other activities supported by Sobi local PV contacts through interaction with Global Process Owners.
    • Being responsible for ensuring CAPAs related to PV activities in the assigned countries are appropriate to the issue concerned and closed on time.
    • Maintaining a high degree of understanding and awareness of new Pharmacovigilance trends and developments and collaborating with GPV, local PV, and vendors to ensure Sobi PV activities remain current.
    • Supporting the management and maintenance of the Pharmacovigilance System Master File (PSMF) including local and partner PSMFs, through delivering regional PV information as required by the PSMF Coordinator.

    Global process development and management

    • Contributing to the continuous improvement of GPV processes, systems, and standards.

    Inspection/Audits

    • Contributing to the GVP audit strategy and audit schedule.
    • Supporting the PV audit and inspection readiness activities at the local level.
    • Supporting PV inspections and audits (internal/external), including pre-inspection/audit request and support during inspections/audits.
    • Supporting responses and CAPAs to inspections and audits with a focus on affiliate level and managing the closeout of CAPAs.

    Qualifications

    Education/Learning Experience/Work Experience

    Required:

    • University-level qualification in biosciences, healthcare, or pharmacy.
    • At least 5 years of professional work experience in the Pharmaceutical industry with a minimum of 2 years of experience within the Pharmacovigilance department.

    Desired:

    • Pharmacovigilance experience from working within both the local and global levels.
    • System and process development, implementation, and improvement.

    Skills/Knowledge/Languages

    Required:

    • Expert knowledge of PV-related regulatory requirements, including an understanding of PV processes and international guidelines (including Good Pharmacovigilance Practices (GVP) and ICH Guidelines).
    • Working across teams to develop a holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders.
    • Being a strong collaborator and problem solver.
    • Quality mindset including CAPA management.
    • Fluency in English.
    • Computer literate.

    Additional Information

    Personal Attributes

    Required:

    • Strong communication skills, including across geographies and functions.
    • Strong analytical/problem-solving skills and attention to detail.
    • Ability to manage multiple activities simultaneously.
    • Ability to independently plan, organize, coordinate, and execute assigned tasks.
    • Understanding the requirements of diverse stakeholders and conflict resolution management.
    • Delivery focused with the ability to exercise judgment, make decisions, and take action to complete assignments.
    • Able to work collaboratively.

    In addition, you should exemplify our core values: Ambition, Ownership, Partnership, and Care.

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