• Job Description

  Req#: IONIS003268

  Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

  As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

  Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

  EXECUTIVE DIRECTOR, DRUG SAFETY SURVEILLANCE

  SUMMARY:

  The Executive Director of Drug Safety Surveillance provide safety science and pharmacovigilance support to molecules across the entire Ionis portfolio. Major areas of responsibilities include signal detection activities for pre- and post-marketed products, including review and evaluation of aggregate safety data, safety review meeting coordination, and production of Risk Management Plans, periodic safety reports, and other PV documents. Primary accountability – Strategic planning and oversight of vendors; timely delivery of safety regulatory documents; Collaboration with Drug Safety Physicians (DSP) on activities supporting proactive risk management through timely identification of safety signals. This position will report to the Vice President and Head of Drug Safety/Pharmacovigilance or the Head of Drug Safety Surveillance.

  RESPONSIBILITIES:

  • Manage the overall planning, oversight and timely development and submission of safety-related regulatory documents including DSURs/IND Annual Reports, PADERs, PSURs/PBRERs, ad-hoc safety requests from Health Authorities, and other global periodic safety reports
  • Support the development and review of appropriate safety sections of key product documents including: IBs (including RSIs), study protocols, ICF, CCDS, RMP, REMS
  • Perform routine review and evaluation of aggregate safety data from ongoing studies, including common AEs, lab abnormalities, etc., and provide summary of the results in collaboration with the DSPs
  • Support safety signal detection and assessment activities, including identification and validation of possible trends and concerns related to Ionis products and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
  • Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
  • Oversee literature surveillance, identify safety issue from published medical literature, summarize relevant publications for inclusion in safety periodic reports
  • Support projects or other initiatives from cross functional groups and departments (Clinical Development, Regulatory Affairs, Quality and Toxicity), ensure adequate safety support and timely update of safety information to drug safety physicians
  • Support the development of Ionis Drug Safety infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
  • Provide direct management and mentorship to Safety Surveillance Scientists
  • Will bring safety expertise to interactions with internal stakeholders, Regulatory Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting.
  • Monitor industry best practices, changes in global safety regulations and guidelines for marketed and investigational products and recommends changes and upgrades to existing departmental policies, SOPs, and systems as appropriate
  • May also participate in other activities as required to support the day-to-day functioning of the Drug Safety group

  REQUIREMENTS:

  • Master’s degree in life sciences with a minimum of 12 years’ experience in pharmacovigilance in a pharmaceutical or biotechnology company; Doctorate degree preferred, with at least 8 years’ experience in pharmacovigilance in a pharmaceutical or biotechnology company
  • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
  • Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment).
  • Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize scientific data.
  • Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
  • Ability to work independently, to manage work priorities, to build to build collaborative team relationships at all levels and remain flexible to the needs of the teams/projects

  Please visit our website, http://www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003268

  Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

  Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

  The pay scale for this position is $241,975 to $330,000

  NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

  Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

• About the company

  Ionis Pharmaceuticals is a biotechnology company based in Carlsbad, California that specializes in discovering and developing RNA-targeted therapeutics.

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