Drug Safety Specialist; Remote

• 100% Remote Opportunity
• 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
• Location:
  
  100% Remote within the United States

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.

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.

• 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

• 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

• 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

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

• 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

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

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…