Drug Safety Specialist (Remote)

Drug Safety Specialist

Employment Type: Contract-to-Hire

Pay Rate: $35.00/hour

Schedule: Full-Time 40-hours per week, Monday-Friday 8:00AM - 5:00PM EST (with a one-hour lunch break)

Remote: 100% Remote within the United States

About the Opportunity

TEKsystems is partnering with a rapidly growing pharmaceutical organization to identify an experienced Drug Safety Specialist to join their Pharmacovigilance team. This is an exciting opportunity to support a growing product portfolio and play a critical role in ensuring patient safety and regulatory compliance through adverse event management, safety surveillance, and case processing activities. The team is expanding due to recent product growth and is seeking a professional who can immediately contribute in a fast-paced environment.

Position Overview

The Drug Safety Specialist will be responsible for end-to-end pharmacovigilance activities, including adverse event intake, Individual Case Safety Report (ICSR) processing, safety case review, regulatory reporting support, and pharmacovigilance compliance activities. This position requires a strong understanding of drug safety regulations, case processing workflows, and post-marketing safety surveillance.

Key Responsibilities

• Perform end-to-end processing of Individual Case Safety Reports (ICSRs)
• Receive, document, evaluate, and process Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs)
• Conduct follow-up activities with healthcare professionals, patients, and other reporters to obtain complete case information
• Perform medical review activities and ensure reportability assessments meet regulatory requirements
• Support submissions to regulatory authorities and maintain compliance with applicable reporting timelines
• Perform reconciliation activities related to safety cases and reporting
• Assist with the preparation and review of aggregate safety reports, including PADERs, PSURs, and DSURs
• Support signal detection and signal management activities
• Collaborate with cross-functional internal teams, external partners, and vendors
• Maintain compliance with company SOPs, pharmacovigilance procedures, FDA regulations, and ICH guidelines
• Support audits, inspections, process improvements, and pharmacovigilance documentation activities

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related scientific discipline
• Minimum 3-5 years of Pharmacovigilance and/or Drug Safety experience within a pharmaceutical, biotechnology, or CRO environment
• Hands-on experience performing end-to-end ICSR case processing
• Experience managing Adverse Event (AE) and Serious Adverse Event (SAE) reporting
• Experience supporting post-marketing safety and/or clinical trial safety activities
• Working knowledge of FDA regulations and ICH guidelines
• Experience conducting safety case review and assessment activities
• Strong organizational, analytical, and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work independently in a fully remote environment

Preferred Qualifications

• PharmD, RN, MD, or other advanced healthcare/scientific degree
• Experience with signal detection and safety surveillance activities
• Experience preparing or supporting aggregate safety reports (PADER, PSUR, DSUR)
• Experience working with pharmacovigilance databases such as Argus, ArisG, Oracle Safety, or similar systems
• Experience participating in audits, inspections, or quality/compliance initiatives
• Experience managing post-marketing drug safety activities

Ideal Candidate Background

Candidates with experience in the following titles are strongly encouraged to apply:

• Drug Safety Specialist
• Drug Safety Associate
• Sr Drug Safety Associate
• Pharmacovigilance Specialist
• Pharmacovigilance Associate
• Safety Scientist
• Drug Safety Coordinator
• Sr Pharmacovigilance Specialist

Why Join?

• 100% Remote Opportunity
• Competitive Pay at $35.00/hour
• Contract-to-Hire Career Path
• Join a Growing Pharmaceutical Organization
• Opportunity to Support an Expanding Product Portfolio
• High-Impact Role Focused on Patient Safety and Regulatory Compliance
• Collaborative and Growth-Oriented Team Environment

Apply today if you have hands-on Pharmacovigilance or Drug Safety experience and are looking for a fully remote opportunity where you can make an immediate impact.

Job Type & Location

This is a Contract to Hire position based out of Princeton, NJ.

Pay and Benefits

The pay range for this position is $35.00 - $35.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 13, 2026.

About TEKsystems

We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

About TEKsystems and TEKsystems Global Services

Were a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. Were a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. Were strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. Were building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.