Associate Director, QPPV Office and Pharmacovigilance System Master File (PSMF)
Apply locations: Warsaw, UK - Surrey - Weybridge, Weybridge – Headquarters Time type: Full time Posted on: Posted Yesterday Time left to apply: End Date: February 7, 2025 (28 days left to apply) Job requisition id: 527759 Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. About the role Description / Position purpose: Support Haleon’s Qualified Person Responsible for Pharmacovigilance in fulfilling activities per GVP module I. Coordinate QPPV Office daily activities and support QPPV by ensuring appropriate oversight of global PV system. Manage the EU/Global Pharmacovigilance System Master File (PSMF). Drive strategy to develop a fit-for-purpose process required to support global PSMF requirements. Act as EudraVigilance Trusted Deputy. ACCOUNTABILITIES/RESPONSIBILITIES Support Haleon’s Qualified Person Responsible for Pharmacovigilance in fulfilling activities per GVP module I. Coordinate QPPV Office daily activities and maintain QPPV documentation appropriately. Facilitate QPPV network & forums to provide EU-QPPV oversight, share learnings and best practice, support and embed the global QPPV model. Provide input into strategic discussions to improve the collection and collation of data for EU QPPV oversight. EU/Global PSMF updates to ensure it is current and inspection ready. Responsible for the maintenance of the Summary of the PV System. Maintain a detailed awareness of regulatory requirements and other publicly available information affecting the PSMF, including equivalent document for non-medicinal products and for communicating it to impacted stakeholders. Maintain PSMF SOP, related template(s) and other written standards to identify areas for ongoing improvement of the PSMF and PSMF process and to implement changes as needed. Train stakeholders and subject matter experts on updates to the PSMF process. Provide guidance and support to non-EU LOCs when non-EU legislation requires a local PSMF to be developed. Plan and execute specific PSMF projects including updates arising from specific business deals. Act as EudraVigilance Trusted Deputy and drive strategy and set up process for EudraVigilance access management and maintenance. Provide support to regulatory inspections as required. QUALIFICATIONS Degree in Life Sciences or equivalent. COMPETENCIES AND SKILLS Expertise in Pharmacovigilance legislation. Minimum 10-15 years of experience in Pharmacovigilance. Demonstrated experience in working in pharmacovigilance (PV) or closely aligned to PV with a good understanding of the global PV organisation including local PV activities, PV systems, case management and safety evaluation in order to work with Subject Matter Experts and PSMF material in a meaningful way. An excellent understanding of the key interfaces with pharmacovigilance such as Regulatory, Clinical, Compliance. Excellent and verifiable project management and organisational skills. A highly collaborative approach to work is essential. A good level of understanding of EU and global PV legislation as well as non-medicinal legislation. Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/. At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Accommodation Requests: If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
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Apply locations: Warsaw, UK - Surrey - Weybridge, Weybridge – Headquarters Time type: Full time Posted on: Posted Yesterday Time left to apply: End Date: February 7, 2025 (28 days left to apply) Job requisition id: 527759 Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. About the role Description / Position purpose: Support Haleon’s Qualified Person Responsible for Pharmacovigilance in fulfilling activities per GVP module I. Coordinate QPPV Office daily activities and support QPPV by ensuring appropriate oversight of global PV system. Manage the EU/Global Pharmacovigilance System Master File (PSMF). Drive strategy to develop a fit-for-purpose process required to support global PSMF requirements. Act as EudraVigilance Trusted Deputy. ACCOUNTABILITIES/RESPONSIBILITIES Support Haleon’s Qualified Person Responsible for Pharmacovigilance in fulfilling activities per GVP module I. Coordinate QPPV Office daily activities and maintain QPPV documentation appropriately. Facilitate QPPV network & forums to provide EU-QPPV oversight, share learnings and best practice, support and embed the global QPPV model. Provide input into strategic discussions to improve the collection and collation of data for EU QPPV oversight. EU/Global PSMF updates to ensure it is current and inspection ready. Responsible for the maintenance of the Summary of the PV System. Maintain a detailed awareness of regulatory requirements and other publicly available information affecting the PSMF, including equivalent document for non-medicinal products and for communicating it to impacted stakeholders. Maintain PSMF SOP, related template(s) and other written standards to identify areas for ongoing improvement of the PSMF and PSMF process and to implement changes as needed. Train stakeholders and subject matter experts on updates to the PSMF process. Provide guidance and support to non-EU LOCs when non-EU legislation requires a local PSMF to be developed. Plan and execute specific PSMF projects including updates arising from specific business deals. Act as EudraVigilance Trusted Deputy and drive strategy and set up process for EudraVigilance access management and maintenance. Provide support to regulatory inspections as required. QUALIFICATIONS Degree in Life Sciences or equivalent. COMPETENCIES AND SKILLS Expertise in Pharmacovigilance legislation. Minimum 10-15 years of experience in Pharmacovigilance. Demonstrated experience in working in pharmacovigilance (PV) or closely aligned to PV with a good understanding of the global PV organisation including local PV activities, PV systems, case management and safety evaluation in order to work with Subject Matter Experts and PSMF material in a meaningful way. An excellent understanding of the key interfaces with pharmacovigilance such as Regulatory, Clinical, Compliance. Excellent and verifiable project management and organisational skills. A highly collaborative approach to work is essential. A good level of understanding of EU and global PV legislation as well as non-medicinal legislation. Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/. At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Accommodation Requests: If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
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