Adverse Events, Biotech and Pharmaceutical, Corporate Compliance, Cross-Functional, Data Entry, Data Quality, Documentation, Healthcare, Maintain Compliance, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Open Systems Interconnection (OSI), Patient Assessment, Pharmacovigilance, Product Safety, Regulations, Regulatory Submissions, Safety/Work Safety, Standard Operating Procedures (SOP), Surveillance
Responsible for performing pharmacovigilance activities and maintaining compliance to corporate and departmental goals and worldwide regulatory timelines for OSI products. The Safety Associate works fairly independently in receiving and reviewing serious adverse event (SAE) reports for completeness, performing initial triage, data entry into the Safety database and quality review of data. Obtains follow-up information as necessary. Performs routine data queries and generates routine and adhoc reports. Creates and maintains SAE source documentation and files. The Safety Associate is responsible for preparation of expedited and periodic regulatory safety submissions and authoring the safety sections of study reports and annual reports. The Safety Associate helps identify safety signals, provides safety data queries and summaries and participates in workflow modifications, SOP updates, clinical project teams and other interdepartmental teams as necessary.
Responsible for performing pharmacovigilance activities and maintaining compliance to corporate and departmental goals and worldwide regulatory timelines for OSI products. The Safety Associate works fairly independently in receiving and reviewing serious adverse event (SAE) reports for completeness, performing initial triage, data entry into the Safety database and quality review of data. Obtains follow-up information as necessary. Performs routine data queries and generates routine and adhoc reports. Creates and maintains SAE source documentation and files. The Safety Associate is responsible for preparation of expedited and periodic regulatory safety submissions and authoring the safety sections of study reports and annual reports. The Safety Associate helps identify safety signals, provides safety data queries and summaries and participates in workflow modifications, SOP updates, clinical project teams and other interdepartmental teams as necessary.
Bachelors degree preferably in a healthcare discipline and two or more years experience in a healthcare environment or the pharmaceutical industry Preferably in safety surveillance or related area. Must be proficient with MS Word, Excel, and PowerPoint
Skills & Requirements
Bachelors degree preferably in a healthcare discipline and two or more years experience in a healthcare environment or the pharmaceutical industry Preferably in safety surveillance or related area. Must be proficient with MS Word, Excel, and PowerPoint