Product Safety Specialist

Job Title: Product Safety Specialist
Location: Remote, NJ
Duration: 6 Months+ (Possible Extension)

Pay Range: $40 – $48.57/hr. (W2)
 
Key Responsibilities:

• Receive, document, and process safety information for marketed and investigational products.
• Interact with healthcare professionals and consumers to collect adverse event reports and perform follow-ups.
• Provide accurate product information to healthcare professionals, consumers, and sales representatives.
• Code and enter adverse events into global safety database (PSSS/ARISg), ensuring accuracy, completeness, and regulatory compliance.
• Maintain case consistency and prepare regulatory reports for FDA and other health authorities.
• Conduct follow-up as per guidelines, maintaining thorough communication documentation.
• Maintain in-depth knowledge of products’ core data sheets, labeling, and investigational materials.
• Participate in training and validation processes for safety databases.
• Provide professional customer service and ensure timely submission of regulatory reports to affiliates, partners, and regulatory bodies.

• 65% – Case processing, data entry, follow-up, coding (ARISg/MedDRA)
• 15% – Regulatory submissions and confirmations
• 10% – Product knowledge and customer service
• 10% – Training and SOP compliance

• Education: Bachelor’s degree in a medical field with RN or RPh licensure, or PharmD/MD degree.
• Experience:
  • 2–4 years in clinical medicine/pharmacy industry.
  • Minimum 1 year in pharmaceutical drug safety.
  • Experience with AE/SAE, PSUR/ICSR, DSUR, PBRER reporting, preferably in oncology/neurology.
  • Experience verbally interviewing or providing medical information to healthcare professionals and consumers.
• Licensure/Certification: Registered Pharmacist (RPh) or RN.
• Skills:
  • Strong understanding of clinical information and medical terminology.
  • High attention to detail.
  • Strong verbal and written communication skills.
  • Proficient in computers and safety database applications (ARISg, MedDRA coding).
  • Ability to work in a fast-paced, professional environment.

• Experience with post-marketing and solicited cases.
• Background in oncology or neurology therapeutic areas.
• Knowledge of standards for patient care and clinical application of medicine.