Ironwood Pharmaceuticals · 13 hours ago
Associate Director, Global Patient Safety Operations
Boston, Massachusetts, United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$167K/yr - $200K/yr
7+ years expIronwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. The Associate Director, Global Patient Safety Operations, is responsible for operational management and oversight of case processing activities, vendor management, and supporting functions such as alliance management, quality & compliance, and safety systems.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide oversight of operational and case management activities for safety reporting for both investigational and marketed products
Managing Case Processing Vendor including oversight of daily responsibilities, providing guidance, training, and evaluating vendor performance and quality of work
Generate performance and compliance metrics for the PV vendor and monitor for trends and possible improvements
Identify and lead needed upgrades to Safety Database functionality in conjunction with Vendor, IT and project management colleagues
Lead and provide safety operations support to Clinical Trial Teams (CTT) on assigned studies including input to protocols, IBs, CSRs and other relevant study documents
Develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions, blinding and unblinding protections and SOPs
Review new or updated PV regulations to identify required modifications to internal Ironwood procedures and/or agreements with vendors or business partners
Maintain inspection readiness and collaborate with internal teams and vendors to prepare for Regulatory Authority inspections and internal/external audits as subject matter expert for PV operations
Contribute to responses to safety requests from Regulatory Authorities and internal teams
Qualification
Required
Bachelor's degree in life sciences; A health professional degree (e.g., PharmD, BSN, RN, MPH) is preferred
7-10 years of relevant experience that includes experience in case processing for US and EU clinical trials
Strong working knowledge of global safety regulations for regulatory authorities such as of FDA, MHRA, EMA (GVP), ICH Guidelines and their specific implications to case processing, patient privacy, and safety databases
Experience with clinical trial data and safety reporting tools such as Argus Safety, Electronic Data Capture, electronic reporting gateways, elluminate platform
Knowledge of MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases
Benefits
Restricted Stock Unit awards
Eligibility to participate in either a bonus or sales incentive program
Company-sponsored 401(k) with matching contributions
Eligibility for medical, dental, vision and prescription drug benefits
Wellness stipends
Generous vacation/holiday schedule
Company
Ironwood Pharmaceuticals
Ironwood Pharmaceuticals is an entrepreneurial pharmaceutical company, develops drugs for gastrointestinal and cardiovascular diseases.
201-500 employees
H1B Sponsorship
Ironwood Pharmaceuticals 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 (1)
2024 (2)
2023 (1)
2021 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$634MKey Investors
Venrock
2016-09-26Post Ipo Debt· $150M
2013-01-10Post Ipo Debt· $175M
2010-02-03IPO
Leadership Team
Thomas McCourt
Chief Executive Officer
Sharon DeBacco
VP Product Promotion & Communication
Recent News
Genetic Engineering News
2026-01-05
Company data provided by crunchbase