- Assess SAE reports which may include data entry and preparation of SAE narratives, as directed by client format, and coding of event terms in Safety database utilizing the Medical Dictionary for Regulatory Activities (MedDRA) dictionary
- Participate in triaging of safety reports for regulatory reporting purposes, interpret clinical data, perform regulatory evaluation and assign causality as applicable; define, initiate and track follow-up information /correspondence through to case closure; ensure entry of SAEs into real-time safety database (Empirica Trace)
- Prepare safety reports according to specified regulatory guidelines and facilitate communication with clinical, regulatory and data management/biostatistics team members for individual clinical trial SAE reports
- Assist in the development and implementation of clinical safety and pharmacovigilance standards, processes, templates and forms e.g., format and content of narrative descriptions, medical assessment and reporting requirements for SAEs to use in support of clinical safety reviews, etc.
- Participate in developing standard output formats for standard tables and listings for Safety data for annual reports and final clinical study reports
- Provide support to study team, investigative sites, and external customers with regard to product safety issues
SKILLS AND EXPERIENCE:
- Demonstrated knowledge of FDA and ICH standards, including 21 CFR Part 11 and use of validated systems and associated processes
MINIMUM EDUCATION: Minimum of a Bachelor’s degree in a health related field with at least 5-7 years of experience in clinical research and 3-5 years’ experience with Clinical Safety Surveillance and or Pharmacovigilance. A Master’s degree, or PharmD will also be accepted.