Description
Responsibilities- Process and assess AEs from receipt to case closure in Argus, including narrative writing
- Evaluate adverse event reports for content and completeness and assess for regulatory reportability
- Ensure timely and adequate resolution of any discrepancies
- Oversee and ensure timely and accurate processing of individual reports and safety reporting to regulatory authorities, investigators and business partners
- Assists with the revision of SOPs and working instruction for the department
- MedDRA coding of SAEs and AEs as reported in source documents of AE reports and development/revision of MedDRA coding conventions ensuring consistent data categorization
- Coordinates and participates on projects for safety signal detection, safety analysis and Pharmacovigilance
- Drafting or contributing to FDA and global periodic safety reports.
Qualifications
- Health care professional (PharmD OR RN) degree or equivalent
- 3+ years of relevant experience in a pharma or biotech company
- General understanding of drug development, safety reporting, FDA and international regulations for AE reporting and knowledge of the importance of regulatory compliance
- Strong computer and database skills, Argus experience a plus