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Associate Medical Director, Medical Safety

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

The Associate Medical Director/ Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product (investigational and marketed) throughout its 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.

Responsibilities, Including But Not Limited To

  • 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



Technical Requirements & Skills

  • MD required (or equivalent); 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.
  • Minimum 1-4 years Drug Safety/Pharmacovigilance experience or 2 or more years clinical development experience; other relevant experience may be considered
  • 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 Skills

  • Set & 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.



Jazz 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.

Associate Medical Director, Medical Safety

Palo Alto, CA
Full Time

Published on 03/26/2020