Nqppv Network Lead
vor 5 Monaten
**Breakthroughs don’t just happen in a lab**
**What makes you stand out, makes you ready to make an impact. At AbbVie**
Welcome to AbbVie As part of an international company with 48,000 employees worldwide you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place
You will be working in a team of talented people and experienced management experts. Location - we are flexible where are you based. Through valuable analyses and research efforts, you will be laying down benchmarks and shaping the future of our brand.
**Together, we break through** **- flexible location - as **National QPPV Network Lead**
**Make your mark**:
- This position supports the_ International and EU QPPV to fulfil the legal requirements to ensure oversight of AbbVie’s PV system. Furthermore, this role ensures that national QPPVs (NQPPVs) meet their legal obligations worldwide. The role is the linchpin to a strong & experienced NQPPV network. Key responsibilities include acting as the primary point of contact for all NQPPVs. This role is critical to the International PV Network, with its goal of delivering an effective Area PV model and executing product PV strategies across AbbVie affiliates._
**Responsibilities**:
- Core member of the global QPPV Network governance committee and active participant in all QPPV oversight meetings. Represents the views and interests of other NQPPVs at such QPPV oversight meetings and shares relevant information.
- Collaborate with area and regional PSEQ International Partners to provide strategic direction to all NQPPVs on local safety quality system organization, optimization and efficiency.
- Supports Medical Advisors in the QPPV Office to educate NQPPVs of the utilization of product safety information at the local level.
- Supports AMDs and Regional PSEQ International Partners in hiring the right talent with necessary qualification, and critical skillsets to meet regulatory requirements as NQPPV.
- Point of contact for NQPPVs and ensures NQPPV communication (learnings, best practice sharing).
- Connects with external environment and shares learnings, insights, and strategies with NQPPVs. Anticipates regulatory changes impacting NQPPV.
- Partners with Area and Regional PSEQ International Partners and global teams to determine the necessary mechanisms for providing ‘fit for purpose’ onboarding and training to support NQPPVs.
- Develop and maintain NQPPV documents (e.g. QPPV toolbox).
- Enhances and monitors performance of outsourced NQPPV.
- Leads community of Excellence for NQPPVs (COE).
- Collaborate with SC and RDQA to support NQPPVs to ensure successful inspection outcomes.
- Partner with RDQA and SC to determine inspection and audit “readiness” framework for N-QPPVs. Share information and support RDQA to build an effective N-QPPV audit strategy (including outsourced NPPVs and distributors)
- Reviews audit / inspection findings and share QPPV related findings with QPPV network.
- Review non-EU PSMFs and supports NQPPV with national PSMF content.
- Advises NQPPVs in Health authorities enquiries and communication.
- Responsible for EU AROS & review of global AROS where a NQPPV is required.
- IPV Affiliate Network Forum Lead (if EU QPPV or deputy is not available).
- Participates and brings relevant topics for NQPPV to the IPV Affiliate Network Forum.
**Qualifications**:
- Bachelor’s or master’s degree in relevant biological science, healthcare discipline (medicine, pharmacy or nursing) or pharmacovigilance.
- At least 7 years in regulated pharmaceutical industry; must have comprehensive working knowledge of EU PV legislative framework.
- At least 7 years practical experience as NQPPV or / and EU QPPV
- Ability to influence other AbbVie functional leaders to achieve cross-functional alignment.
- Adaptable and strong problem-solving abilities.
- Motivational approach, open to new ideas and the ability to connect the dots within and across groups and functions.
- Excellent written and verbal communication skills in English.
**Here's how we can move mountains together**:
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network
Multiple times, we have be
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