Drug Safety Associate encompasses the processing and monitoring of adverse events, reports for investigational and marketed products following company Standard Operating Procedures (SOPs) to ensure compliance with worldwide Safety regulations, Corporate and Regulatory guidance documents, and Corporate Policies.
- Perform triage of adverse event reports for completeness, validity and seriousness in order to prioritize workload
- Process adverse event reports from clinical trials and from marketing activities as per company SOPs and guidelines for maintaining regulatory compliance
- Perform risk and quality function on adverse event reports including manual coding as needed
- Write case narratives
- Prioritize workload for product and liaise with other Safety Associates to ensure timely processing
- Possess working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for post-market and clinical trial environments
- Possess excellent understanding of pharmacology, including drug interactions
- Utilize clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
- Able to comprehend and analyze pharmaceutical literature
- Familiar with common Safety databases (for example, ArisG, AERS, Argus, and so on)
- Possess strong organizational, management, teamwork, communication skills (verbal and written), interpersonal skills and professionalism
- Able to manage multiple projects in a fast-paced environment
- Collaborate effectively with the study team, cross-functional team members and external partners
Eligibility: A minimum of Bachelor’s degree in life sciences, microbiology or related fields, or a healthcare degree in pharmacy, nursing (RN or BSN), MD, physiotherapy or dentistry, or equivalent qualification/work experience.