National QPPV Network Lead
Company Description
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
This position supports the NQPPV Network Lead 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 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:
Bachelor’s or master’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
National QPPV Network Lead
Company Description
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
This position supports the NQPPV Network Lead 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 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:
Bachelor’s or master’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html