Drug Safety Specialist Job Responsibilities
Education and Qualifications
- Responsible for collecting and processing adverse event reports for clinical trials, compassionate use trials, and marketed products.
- Assists in the development of safety surveillance processes and writing corresponding SOPs.
- Assists with other safety surveillance related activities as needed.
- Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAEs are complete prior to database closure
- Process and distributes clinical study SAE reports as per the company SOPs
- Completes AE/SAE reconciliation prior to clinical trial database closure
- Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company's SOPs
- Processes all types of adverse event reports utilizing the ARISg safety database
- Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested
- Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed
- Assists with implementing safety surveillance processes and establishing appropriate SOPs
- Bachelors of Science degree in Nursing or Bachelors degree in a specific discipline with clinical experience
- Minimum of 5 years clinical experience, minimum 3 years pharmaceutical experience with 2 years specific safety surveillance experience
- Microsoft Windows XP, Microsoft Office Suite, Industry recognized safety database (e.g. ARISg or equivalent)
- Excellent interpersonal, communication, and writing skills
- Minimal domestic travel may be required
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.