Assistant Director, Drug Safety Surveillance

Ionis•Carlsbad, CA

6d•Hybrid

About The Position

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! The Assistant Director of Drug Safety Surveillance (PV Scientist) provides safety science and pharmacovigilance support to assigned molecules within Ionis portfolio. Core responsibilities include leading or supporting high quality production of aggregate reports, RMPs/dRMPs, signal evaluation reports, signal detection management (eg, data evaluation, presentation, meeting coordination, etc.), and literature surveillance. This position will report to the Executive Director of Drug Safety Surveillance within Patient Safety and Pharmacovigilance.

Requirements

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).
Ability to interact effectively in a multifunctional and multicultural team setting
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/project
Minimum of Bachelor’s degree in life sciences.
Minimum of 8 years’ experience in pharmacovigilance within a pharmaceutical or biotechnology company; prefer at least 2 years in Safety Surveillance

Nice To Haves

Advanced degree in healthcare profession strongly preferred (e.g., MD, PharmD, PhD)

Responsibilities

Timely development safety-related regulatory documents including DSURs, PADERs, IND Annual Reports, PSURs/PBRERs, ad-hoc safety requests from Health Authorities, and other global periodic safety reports
Support development and review of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, dRMP, REMS
Support routine and ad-hoc signal detection activities for assigned clinical programs and marketed products
Perform literature surveillance, identify safety issue from published medical literature, summarize relevant publications for inclusion in safety periodic reports
Participate in responding to safety queries from Health Authority pertaining to aggregate reports, PASS reports, marketing authorization filing documents, etc.
Support projects or other initiatives from cross functional groups and departments (Clinical Development, Regulatory Affairs, Data Management, Quality, Toxicology, etc.)
May also participate in other activities as required to support Safety Surveillance deliverables, including but not limited to REMS, PASS reports