Ionis Pharmaceuticals, Inc. · 4 hours ago
Associate Director/ Director, Drug Safety Surveillance (PV Scientist)
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$156K/yr - $267K/yr
12+ years expIonis Pharmaceuticals, Inc. is a pioneer in RNA-targeted medicines, headquartered in Carlsbad, California. They are seeking an Associate Director/Director of Drug Safety Surveillance (PV Scientist) to provide safety science and pharmacovigilance support to their portfolio, ensuring high-quality aggregate report production and managing safety signals.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
Responsibilities
Reports, 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 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 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
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, Data Management, Quality, Toxicology, etc.)
Bring safety expertise to interactions with internal stakeholders, Health Authorities and Data Monitoring Committees
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
Qualification
Required
Bachelor's degree in life sciences and 12 years of related 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)
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 collaborative team relationships at all levels and remain flexible to the needs of the teams/projects
Preferred
Advanced degree in healthcare profession strongly preferred (e.g., MD, PharmD, PhD with at least 5 years of related experience)
Benefits
Ionis offers an excellent benefits package!
Company
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.
501-1000 employees
H1B Sponsorship
Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45B2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M
Leadership Team
Brett P. Monia
Chief Executive Officer
Eric Bastings
Senior Vice President, Development Strategy
Recent News
Labiotech UG
2026-01-22
Business Wire
2026-01-22
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