Sr Drug Safety Scientist (Pharmacovigilance)

Location: Lake Zurich, Illinois, United States; hybrid with onsite work 3 days per week. Applicants must be authorized to work for any employer in the United States. Visa sponsorship is not available.

Salary: $133,000–$146,000 per year, plus eligibility for a bonus plan with a target of 10% of base salary.

Company

hirify.global develops and provides pharmaceutical, nutrition, and biological products.

What you will do

• Lead the receipt, assessment, follow-up, processing, and reporting of global adverse drug events in line with SOPs, FDA regulations, and global requirements.
• Perform peer review in KabiSafe LSMV and the Global Complaint Management Workflow for Drug Safety Scientists and Data Specialists.
• Coordinate with Global Vigilance medical reviewers, Quality, Regulatory, and partner organizations to resolve safety and quality issues.
• Prepare and oversee Periodic Adverse Drug Experience Reports and individual case safety reports.
• Support training, procedure development, SDEA management, ADE reconciliation, and REMS implementation and monitoring.
• Identify potential compliance issues and contribute to solutions that maintain compliant case processing.

Requirements

• Current medical or clinical professional degree in good standing, such as PharmD, RPh, or RN.
• Minimum 8 years of drug safety and adverse drug event reporting experience.
• Strong clinical judgment, critical thinking, organization, collaboration, leadership, and multitasking skills.
• Ability to interpret federal regulations and SOPs, create medically appropriate case narratives, and identify potential product quality issues and health hazards.
• Experience with Aris global systems, MedDRA/WHO drug coding, and Microsoft Office Suite.
• Effective spoken and written English is required, along with U.S. work authorization without current or future visa sponsorship.

Nice to have

• Clinical or hospital experience and post-marketing pharmaceutical industry experience.
• Experience preparing PADERs, managing SDEAs, and operating REMS programs.
• Experience with LifeSphere MultiVigilance.

Culture & Benefits

• Cross-functional and collaborative work with Global Vigilance, Quality, Regulatory, and external partners.
• Medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions, paid vacation, holidays, and personal days.
• Employee assistance, life insurance, disability coverage, and wellness programs.
• Work is performed in accordance with health, safety, environment, energy, and quality management systems.