Senior Medical Director, Medical Safety - Remote
If you are a Jazz employee please apply via the Internal Career siteJazz 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.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
For more information, please visit www.
jazzpharmaceuticals.
com and follow @JazzPharma on Twitter.
This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position.
This description will be reviewed periodically and revised as duties and responsibilities change with business demands.
Other duties not listed above may be assigned as needed.
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 manager junior employee, either directly, or in matrix management, and provide mentorship and leadership.
She/ he will lead the therapy area focused teams, and together with the head of medical safety decide on appropriate resourcing for product support, and process improvement.
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 excellenceProvide PV leadership to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned productsLead 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 productsDirect 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 labelingPerform 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 stakeholdersLead and/or participate on Safety Management Team (SMT) and other executive forums for assigned productsContribute 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 productsLead 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 requirementsProvide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety dataDevelop 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 standardsActively involved in inspection readiness activities, internal audits and external inspectionsRepresent PV in cross-functional forums and committees to achieve the Company s goalsParticipate 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 excellenceProvide safety expertise to due diligence activities as neededMaintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assignedKeeps abreast of new PV/safety regulations and guidance from the regulatory authoritiesMentor junior DSPV staff; develop and provide training within specific areas of knowledgeRequired 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 processesExposure to working relationship with the FDA and other regulatory authorities is preferredWorking knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systemsMedDRA trained and working knowledge of MedDRA and WHODrug coding dictionariesWorking experience with PV audit process with active participation in Regulatory Authority InspectionsAbility to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this positionExcellent knowledge of drug development processRequires a high level of initiative and independenceMust have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamworkComputer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and WordSome national/international travel may be requiredLeadership 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 LicensesMD 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 plusJazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc.
is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
For this role, the anticipated base pay range is $216,000-$283,500.
The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package.
The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
For more information on our Benefits offerings please click here:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
For more information, please visit www.
jazzpharmaceuticals.
com and follow @JazzPharma on Twitter.
This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position.
This description will be reviewed periodically and revised as duties and responsibilities change with business demands.
Other duties not listed above may be assigned as needed.
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 manager junior employee, either directly, or in matrix management, and provide mentorship and leadership.
She/ he will lead the therapy area focused teams, and together with the head of medical safety decide on appropriate resourcing for product support, and process improvement.
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 excellenceProvide PV leadership to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned productsLead 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 productsDirect 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 labelingPerform 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 stakeholdersLead and/or participate on Safety Management Team (SMT) and other executive forums for assigned productsContribute 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 productsLead 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 requirementsProvide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety dataDevelop 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 standardsActively involved in inspection readiness activities, internal audits and external inspectionsRepresent PV in cross-functional forums and committees to achieve the Company s goalsParticipate 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 excellenceProvide safety expertise to due diligence activities as neededMaintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assignedKeeps abreast of new PV/safety regulations and guidance from the regulatory authoritiesMentor junior DSPV staff; develop and provide training within specific areas of knowledgeRequired 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 processesExposure to working relationship with the FDA and other regulatory authorities is preferredWorking knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systemsMedDRA trained and working knowledge of MedDRA and WHODrug coding dictionariesWorking experience with PV audit process with active participation in Regulatory Authority InspectionsAbility to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this positionExcellent knowledge of drug development processRequires a high level of initiative and independenceMust have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamworkComputer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and WordSome national/international travel may be requiredLeadership 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 LicensesMD 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 plusJazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc.
is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
For this role, the anticipated base pay range is $216,000-$283,500.
The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package.
The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
For more information on our Benefits offerings please click here:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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