Safety Specialist

Overview

We are seeking a detail-oriented and scientifically driven Drug Safety Specialist to join our Pharmacovigilance team in Atlanta, GA. This role is responsible for monitoring, evaluating, and reporting adverse events and other safety information to ensure compliance with FDA and global regulatory requirements. The ideal candidate will have strong analytical skills, knowledge of drug safety regulations, and experience working in a pharmaceutical or biotech environment.

• Review, assess, and process adverse event (AE) reports from clinical trials, post-marketing surveillance, and spontaneous reports.
• Perform medical coding using MedDRA and WHO Drug dictionaries.
• Conduct case narrative writing and ensure accurate data entry into safety databases.
• Prepare and submit expedited and periodic safety reports (e.g., SUSARs, PSURs, DSURs) to regulatory authorities, including the FDA.
• Support signal detection and risk management activities.
• Collaborate with Clinical, Regulatory Affairs, Quality Assurance, and Medical Affairs teams.
• Ensure compliance with global pharmacovigilance regulations and internal SOPs.
• Assist with audits and inspections by regulatory agencies.
• Contribute to process improvements and safety documentation updates.

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (advanced degree preferred).
• 2–5 years of experience in pharmacovigilance or drug safety within a pharmaceutical or biotech company.
• Knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements.
• Experience with safety databases (e.g., Argus, ARISg).
• Strong written and verbal communication skills.
• High attention to detail and strong organizational skills.
• Ability to manage multiple deadlines in a fast-paced environment.

• Advanced degree (Pharm
  
  D, MPH, MS, or related).
• Experience with signal detection tools and aggregate report writing.
• RAC certification or other regulatory certifications.
• Experience supporting global clinical trials.
• Analytical and critical thinking
• Regulatory compliance knowledge
• Scientific writing
• Cross-functional collaboration
• Problem-solving and decision-making