The job below is no longer available.

You might also like

in Philadelphia, PA

Use left and right arrow keys to navigate
Hours Full-time, Part-time
Location Philadelphia, Pennsylvania

About this job

Overview:

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.


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.

Responsibilities:

Senior Director will oversee two important teams within the Medical Safety function at Jazz Pharmaceuticals: Clinical Safety Management, and Medical Review team. This is a critical position for our PV organization, and will report to the Executive Director of Medical Safety.

This role would have significant managerial responsibilities, to supervise and ensure quality performance of medical review and clinical safety management teams, in compliant manner and aligned with present regulatory guidance. The Senior Director will assure optimal support of all Jazz sponsored as well as investigator initiated studies for Jazz products and programs in all PV operational aspects of study. As head of Medical Review team, the Sr Director will manage a group of medical reviewers who conduct case review activities including assuring medical accuracy, appropriate coding and causality, as well as performing analyses of similar cases as required. Working closely with Product safety physicians, the Senior Director serves as a liaison between the Medical Safety team the Global Case Management team and other PV departments to provide medical standards and guidance for processing of safety cases.

This role would be part of Medical Safety leadership team, and will be closely involved with resourcing, collaboration with other teams within safety as well as other cross-functional teams, such as clinical operations, clinical development, regulatory, compliance, etc.

This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
 

Location: Palo Alto or Philadelphia, Remote


Responsibilities, Including But Not Limited To

  • Ensures the PV Clinical Safety team input to optimize the delivery of JP R&D studies with appropriate study support activities. These include, but are not limited to study start up, close up, AE reconciliation, and coding, database configuration, clinical case processing, and all case medical review, in collaboration with Global Case Management and other PV Operational teams.
  • Serves as the Business Process Owner for PV processes supporting R&D studies.
  • Ensures the PV Medical Reviewer’s team provides robust medical review of ICSRs (pre- and post-marketing), including coding, seriousness, expectedness and Company causality assessment for Jazz products
  • Ensure that appropriate medical interpretation and consistency are applied to AE case assessment
  • Establishes processes and oversight for Medical Review team to work with clinical and safety counterparts, as needed, regarding ICSR handling medical interpretation, case processing, literature, etc.
  • Review and update of the MedDRA coding conventions and EU IME list.
  • Provide training as needed for ICSR assessment and processing
  • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data
  • Develop or contribute to development of relevant Jazz Pharmaceuticals and PV department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.)
  • 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)
  • Establishes and oversees key performance indicators to ensure PV excellence for Clinical Safety and Medical Review
  • Provide safety expertise to due diligence activities as needed
  • Assures Medical Review Physicians develop Product profiles for JP products to enable case processing team to optimize ICSR development
  • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities
  • Mentor junior staff; develop and provide training within specific areas of knowledge, such as medical review, and clinical safety management

Education and Experience

  • MD desirable, but another advanced degree in combination with the relevant experience in pharma industry would be considered; clinical research and/or fellowship training in neurology, hematology, oncology, genetics, pediatrics, endocrinology, metabolism, pharmacology or other relevant specialty is a plus.
  • Minimum 8  years Drug Safety/Pharmacovigilance experience in pharma/biopharma or service provider organization, 3 years of ICSR Medical review experience;
  • Either 2 years of experience in a pharmacovigilance role with clinical safety responsibilities or clinical development activities or other relevant experience may be considered

Skills and Capabilities

  • Excellent understanding of global PV regulatory environment and 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, pharmacovigilance processes and global regulatory reporting requirements
  • Strong knowledge of compliance and quality in the context of PV in drug development and medical case review
  • 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 Employer.