Executive Director, Safety & Pharmacovigilance (PV)

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, SAFETY & PHARMACOVIGILANCE (PV)
Summary
The Executive Director of Safety & PV is responsible for the clinical safety strategy for assigned drug projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Oversight Committee (SOC) and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements. Major areas of responsibility include continuous efficient evaluation of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with Ionis partners. This position reports to the VP and Head of Safety & PV.
Responsibilities

• Leads product risk characterization and benefit/risk assessment activities encompassing proactively identifying through individual case review reports or aggregate reviews new signals, and evaluating the signals and providing risk minimization measure, and communicating those issues through Head of Safety
• Ability to put together coherent risk assessment and mitigating strategies and present with set of recommendations to the Safety Oversight Committee for feedback and endorsement
• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides medical review of case narratives for medical content, accuracy, and signal detection
• Interpret aggregate safety data for periodic reports and evaluating for potential new signals
• Lead signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds
• Lead risk management and risk mitigation activities, including medical and safety leadership for RMPs and aRMMs
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict/establish the safety profile of compounds in clinical development
• Accountable for medical content and safety messaging in aggregate reports (PBRERs, DSURs, IBs) and responses to Health Authority requests, as well as capability in offering medical judgment on complex safety issues
• Determines the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor and/or medical lead.
• Presents safety data to DSMBs for assigned products
• Collaborates with partner company’s drug safety teams and clinicians, and provisions regular safety summaries
• Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Contributes to the maintenance of the pharmacovigilance system and processes
• Participates in SOP updates, audits, and inspection readiness
• Writes/updates core safety information for assigned projects
• Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND submissions, annual reports, etc.)
• Prepares and/or reviews safety documents and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and/or trains external personnel/parties involved in Ionis’ clinical studies.
• Provide clinical education support for internal company customers
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• Participates in writing of white papers and other internal scientific publications.
• Assist in accomplishing department and corporate objectives
• May be required to act as medical monitor for some clinical trials
• May participate/present safety material to Investigator’s meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors.
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned
  

Requirements

• Medical degree (e.g., MD, MBBS)
• At least 5 years of safety experience post-registration
• Extensive experience supporting safety filing activities, or leading activities in signal detection and supporting aggregate reports (DSUR, PADERs & PBRERs)
• Experience submitting reports of periodic review of aggregate safety data to Health Authorities in the US, UK and Republic of Ireland
• Safety experience supporting NDA/MAA submissions
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 8 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)
  

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003270
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%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $301,734 to $356,353
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.