Assistant Director/ Associate Director- Drug Safety/ Surveillance
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
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 individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
ASSISTANT DIRECTOR/ ASSOCIATE DIRECTOR- DRUG SAFETY/ SURVEILLANCE
- Manage the overall planning, oversight and timely development and submission of safety-related regulatory documents including DSURs, IND Annual Reports, PSURs/PBRERs, other global periodic safety reports
- Support the development and review of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS
- Support review of individual case safety reports (ICSRs/SAEs) throughout the life cycle of Ionis products, including narrative review of SUSARs, and including generation of Analysis of Similar Events as needed
- Perform ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports
- 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
- Review and draft SAE narratives to support clinical development activities including CSR, interim analysis, business partner reports, review and QC CSR safety sections
- 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
- Perform 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
- Supports 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
- May also participate in other activities as required to support the day-to-day functioning of the Drug Safety group
- Education: Master in life sciences, PharmD, RPh, PhD, RN, PA
- Experience: minimum 5-year 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 clinical and safety 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 collaborative team relationships at all levels and remain flexible to the needs of the teams/projects
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0188
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.