Job Description
Job Title
Safety Specialist - Mexico and Argentina Hybrid
Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assist in the processing of ICSPR according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSPR, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintains safety tracking for assigned activities.
- Perform literature screening and review for...