Jazz Pharmaceuticals
Senior Medical Director, Medical Safety (MD)
Jazz Pharmaceuticals, Austin, Texas, us, 78716
If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.Brief Description:The
Senior Medical Director/ Global Safety Physician
serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout their lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. This individual will manage junior employees, either directly, or in matrix management, and provide mentorship and leadership.Essential Functions:Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.Provide PV leadership to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products.Lead the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed.Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.Lead and/or participate on Safety Management Team (SMT) and other executive forums for assigned products.Contribute to the preparation and review of pre- and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.Lead risk-benefit evaluations and contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.Develop or contribute to development of Jazz Pharmaceuticals and PV department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.).Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.Actively involved in inspection readiness activities, internal audits and external inspections.Represent PV in cross-functional forums and committees to achieve the Company's goals.Participate in the PV vendor selection activities and contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).Contribute to key performance indicators to ensure PV excellence.Provide safety expertise to due diligence activities as needed.Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned.Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.Mentor junior DSPV staff; develop and provide training within specific areas of knowledge.Required Knowledge, Skills, and Abilities:Technical Requirements and SkillsMinimum 2-4 years Drug Safety/Pharmacovigilance experience; oncology safety experience preferred.Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas, European Union, Latin-America and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes.Exposure to working relationship with the FDA and other regulatory authorities is preferred.Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems.MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries.Working experience with PV audit process with active participation in Regulatory Authority Inspections.Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position.Excellent knowledge of drug development process.Requires a high level of initiative and independence.Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.Some national/international travel may be required.Leadership SkillsSet & Achieve Goals:
Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.Inspire & Mobilize Others:
Serve as a positive role model - create followership and effectively mobilize and influence others, both on your team and across the organization.Provide Ongoing Coaching & Feedback:
Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.Required/Preferred Education and Licenses:MD required; medical licensure in at least one state preferred; clinical research and/or fellowship training in genetics, pediatrics, endocrinology, metabolism, pharmacology or other relevant specialty is a plus.At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.
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Senior Medical Director/ Global Safety Physician
serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout their lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. This individual will manage junior employees, either directly, or in matrix management, and provide mentorship and leadership.Essential Functions:Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.Provide PV leadership to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products.Lead the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed.Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.Lead and/or participate on Safety Management Team (SMT) and other executive forums for assigned products.Contribute to the preparation and review of pre- and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.Lead risk-benefit evaluations and contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.Develop or contribute to development of Jazz Pharmaceuticals and PV department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.).Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.Actively involved in inspection readiness activities, internal audits and external inspections.Represent PV in cross-functional forums and committees to achieve the Company's goals.Participate in the PV vendor selection activities and contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).Contribute to key performance indicators to ensure PV excellence.Provide safety expertise to due diligence activities as needed.Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned.Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.Mentor junior DSPV staff; develop and provide training within specific areas of knowledge.Required Knowledge, Skills, and Abilities:Technical Requirements and SkillsMinimum 2-4 years Drug Safety/Pharmacovigilance experience; oncology safety experience preferred.Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas, European Union, Latin-America and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes.Exposure to working relationship with the FDA and other regulatory authorities is preferred.Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems.MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries.Working experience with PV audit process with active participation in Regulatory Authority Inspections.Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position.Excellent knowledge of drug development process.Requires a high level of initiative and independence.Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.Some national/international travel may be required.Leadership SkillsSet & Achieve Goals:
Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.Inspire & Mobilize Others:
Serve as a positive role model - create followership and effectively mobilize and influence others, both on your team and across the organization.Provide Ongoing Coaching & Feedback:
Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.Required/Preferred Education and Licenses:MD required; medical licensure in at least one state preferred; clinical research and/or fellowship training in genetics, pediatrics, endocrinology, metabolism, pharmacology or other relevant specialty is a plus.At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.
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