National QPPV Network Lead - Europe (all genders)
National QPPV Network Lead - Europe (all genders)
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Job Description
This position supports the NQPPV Network Lead to fulfil the legal requirements to ensure oversight of AbbVies 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 European 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:
- Represents the views and interests of other NQPPVs at QPPV Oversight Meetings and shares relevant information.
- Identify and understand the varied legal requirements across Europe and drivers across markets; apply critical thinking to adapt varied requirements into implementation. Lead and direct NQPPVs in the implementation of relevant obligations.
- Supports Medical Advisors in the QPPV Office to educate NQPPVs of the utilization of product safety information at the local level.
- Supports relevant 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).
- Partners with Area and Global PV Partners to determine the necessary mechanisms for providing fit for purpose onboarding and training to support NQPPVs.
- Develops and maintains NQPPV documents (e.g. QPPV Toolbox).
- Enhances concepts to monitor the performance of outsourced NQPPV.
- Collaborate with relevant internal stakeholders to support NQPPVs to ensure successful inspection outcomes.
- Reviews audit / inspection findings and shares QPPV related findings with QPPV Network.
- Reviews National Pharmacovigilance System Master Files (N-PSMFs).
- Advises NQPPVs in Health Authorities enquiries and communication.
- Participates and brings relevant topics for NQPPV to the QPPV Network Meetings.
Qualifications :
Qualifications:
- Bachelors or masters degree in relevant biological science healthcare discipline (medicine pharmacy or nursing) or pharmacovigilance.
- At least 5 years in regulated pharmaceutical industry; must have comprehensive working knowledge of European PV legislative framework.
- At least 3 years practical experience as NQPPV or / and EU QPPV
- Ability to influence other internal 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.
- Located in Europe.
Additional Information :
What we offer you:
- full remote job within Europe
- a diverse work environment where you can have a real impact
- an open corporate culture
- an attractive salary
- an intensive onboarding process with a mentor at your side
- flexible work models for a healthy work-life balance
- a corporate health management that offers comprehensive health and exercise programs
- company social benefits
- a wide range of career opportunities in an international organization
- top-tier attractive development opportunities
- a strong international network
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
