Drug Safety Specialist

🔥 1 minute ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $35 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👻 Ghost score 0%

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TEKsystems

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🎯 Recruiter

🏢 Enterprise

Consulting • Recruitment • Enterprise

TEKsystems is a global IT and business services firm that provides technology consulting, talent solutions, managed services and workforce recruitment to enterprise clients. The company delivers cloud, digital and data services (including AI/ML and automation), application innovation, Agile/DevOps transformation, technology operations and digital experience work, and operates large-scale talent and managed service programs. TEKsystems works across industries (financial services, healthcare, public sector, telecommunications, retail/manufacturing, energy and more), maintains technology partnerships with major cloud and software providers, and reports more than $7B in annual revenue and 100+ locations worldwide.

📋 Description

• 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 with healthcare professionals, patients, and other reporters to obtain complete case information • Perform medical review activities and reportability assessments • Support submissions to regulatory authorities and maintain compliance with reporting timelines • Perform reconciliation activities related to safety cases and reporting • Assist with 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

🎯 Requirements

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

🏖️ Benefits

• Medical, dental & vision • Critical Illness, Accident, and Hospital coverage • 401(k) Retirement Plan with pre-tax and Roth post-tax contributions • 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) • 100% remote opportunity • Contract-to-Hire career path • Collaborative and growth-oriented team environment