Associate Director/Director, Drug Safety Surveillance (PV Scientist)

1w1 week ago

Ionis Pharmaceuticals

Boston, US · Full-time · $156,033 – $267,284

About this role

Headquartered in Carlsbad, California, with offices in Boston and Dublin, Ionis has discovered medical breakthroughs redefining life for people with serious diseases. Pioneers in RNA-targeted medicines, the company revolutionizes drug discovery for patients with unmet needs in neurology, cardiology, and high-need areas. It advances gene editing to deliver greater value while financially positioned for strategic goals.

The Associate Director/Director of Drug Safety Surveillance provides safety science and pharmacovigilance support to assigned molecules in Ionis portfolio. Responsibilities include ensuring high quality aggregate report production, developing risk management documents with Drug Safety Physicians, and coordinating safety review meetings. The role involves signal detection, evaluating emerging safety data, authoring periodic safety reports, and supporting clinical development.

Ionis cultivates a challenging, motivating environment fostering innovation and scientific excellence. Success stems from exceptional talents and dedication of employees, with investments in onsite, hybrid, and remote work environments. These build solid relationships where culture and employees thrive.

Join to experience unprecedented opportunity to change human health, adding diverse perspectives to the team. Contribute to unique culture while developing and expanding career. Passion for meaningful patient impact aligns with greatest achievements ahead.

Requirements

Expertise in pharmacovigilance and safety science for clinical-stage molecules
Experience authoring periodic safety reports like PSURs/PBRERs and risk management plans
Proficiency in signal detection, assessment, and management from diverse data sources
Knowledge of safety sections in IBs, protocols, ICFs, CSRs, and regulatory documents
Skilled in literature surveillance and evaluation of emerging safety data
Ability to collaborate with Drug Safety Physicians and cross-functional teams
Familiarity with global health authority requirements for safety reporting
Strong analytical skills for reviewing AE data, TFLs, and lab abnormalities

Responsibilities

Ensure high quality of aggregate report production including PSURs/PBRERs, ad-hoc safety requests from Health Authorities, and other global periodic safety reports
Develop and review safety sections of key product documents including IBs (RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS
Review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize results in product safety reports
Support safety signal detection and assessment activities, identifying and validating trends for Ionis and competitive products
Evaluate safety signals through single case reports, aggregate reports, and relevant literature
Perform literature surveillance, identify safety issues from publications, and summarize for periodic safety reports
Coordinate safety review meetings and provide safety support for clinical development
Support cross-functional projects with Clinical Development, Regulatory Affairs, Data Management, Quality