Encompasses the processing and monitoring of adverse events, reports for investigational and marketed products following company Standard Operating Procedures to ensure compliance with worldwide Safety regulations, Corporate and Regulatory guidance documents, and Corporate Policies.
Responsibilities include –
üEvaluates adverse event reports, assesses regulatory status which is seriousness and expectedness/relatedness in order to prioritize workload.
- Processes adverse event reports from clinical trials and from marketing activities as per company Standard Operating Procedures and guidelines for maintaining regulatory compliance.
- Perform risk and quality function on adverse event reports including manual coding as needed.
- Participates in team discussion for both processing and product knowledge.
- Prioritize workload for product and liaise with other Safety Associates to ensure timely processing.
üMay represent safety operations at clinical development meetings
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for post-market and clinical trial environments.
- Excellent understanding of pharmacology, including drug interactions
- Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Ability to comprehend and analyze pharmaceutical literature
- Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
- Familiarity with common Safety databases (e.g., ArisG, AERS, Argus, etc.) preferred.
- Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Collaborate effectively with the study team, cross-functional team members and external partners.