Job Title:
Associate Director, QPPV Office and Pharmacovigilance System Master File (PSMF) Job Location:
Weybridge, UK Job Location Type:
Hybrid Job Contract Type:
Full-time Job Seniority Level:
Director 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. This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. 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. Ensure EU/Global PSMF updates are 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. Maintain PSMF SOP, related template(s) and other written standards to identify areas for ongoing improvement of the PSMF and PSMF process. 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. 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. At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect. 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. Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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Associate Director, QPPV Office and Pharmacovigilance System Master File (PSMF) Job Location:
Weybridge, UK Job Location Type:
Hybrid Job Contract Type:
Full-time Job Seniority Level:
Director 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. This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. 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. Ensure EU/Global PSMF updates are 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. Maintain PSMF SOP, related template(s) and other written standards to identify areas for ongoing improvement of the PSMF and PSMF process. 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. 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. At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect. 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. Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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