Drug Safety Specialist

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee the comprehensive processing of Individual Case Safety Reports (ICSRs)

• Receive, document, evaluate, and manage Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs)

• Conduct follow-ups with healthcare professionals, patients, and other reporters to gather complete case information

• Execute medical review activities and assess reportability

• Assist in submissions to regulatory bodies and ensure adherence to reporting timelines

• Carry out reconciliation tasks related to safety cases and reporting

• Help in the preparation and review of aggregate safety reports, including PADERs, PSURs, and DSURs

• Aid in signal detection and management activities

• Collaborate with cross-functional internal teams, external partners, and vendors

• Ensure compliance with company SOPs, pharmacovigilance procedures, FDA regulations, and ICH guidelines

• Assist with audits, inspections, process enhancements, and pharmacovigilance documentation tasks

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related scientific field

• At least 3-5 years of experience in Pharmacovigilance and/or Drug Safety within a pharmaceutical, biotechnology, or CRO setting

• Practical experience in end-to-end ICSR case processing

• Experience in managing Adverse Event (AE) and Serious Adverse Event (SAE) reporting

• Background in supporting post-marketing safety and/or clinical trial safety activities

• Familiarity with FDA regulations and ICH guidelines

• Experience in conducting safety case reviews and assessments

• Strong organizational, analytical, and problem-solving abilities

• Exceptional written and verbal communication skills

• Capability to work autonomously in a fully remote setup

• PharmD, RN, MD, or other advanced healthcare/scientific degrees preferred

• Preferred experience in signal detection and safety surveillance activities

• Preferred experience in 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 in participating in audits, inspections, or quality/compliance initiatives

• Preferred experience in managing post-marketing drug safety activities

🏝️ Benefits

• Medical, dental & vision coverage

• 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 coverage

• Health Spending Account (HSA)

• Transportation benefits

• Employee Assistance Program

• Time Off/Leave (PTO, Vacation, or Sick Leave)

• 100% remote opportunity

• Contract-to-Hire career progression

• Collaborative and growth-oriented team environment