This position will be responsible for reviewing, reporting and tracking of adverse drug experience reports, assisting with the preparation of aggregate (ASRs, IND annual, and ad-hoc) reports, and all aspects of Pharmacovigilance. The position will have direct impact on the work flow efficiency of patient safety data across internal systems.
- Assist CROs with the receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences received by Pharmacovigilance. Triage events for expectedness and reportability along with the CRO
- Review adverse drug experience reports entered into the Safety Database by a CRO. Review the narratives, follow-up requests, and coding adverse events in MedDRA in conjunction with medical monitors and prepare line-listings and narratives as requested for safety reviews.
- Assist with submission of expedited reports via the CRO to Health Authorities globally. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreements (SDEA) with business partners. Manages expedited submission history in safety database and tracks reporting compliance with regulations.
- Contribute to the timely preparation of ad-hoc and aggregate reports, including DSURs (Developmental Safety Update Reports), 6-monthly SUSAR Line-Listing Reports, IND annual reports, liaising with managers, physicians, and Pharmacovigilance colleagues as appropriate.
- Prepare and maintain internal filing systems; archives safety files and scans source information for archival in electronic systems. Collaborate with internal departments to supports and develop standard operating procedures/working practices/collection forms and adheres to company and departmental SOPs as required.
- Bachelor's degree in a science or healthcare related discipline
- Experience in a medical field (RN, Pharmacy, Pharm. D., PA ) with minimum of 2 years of drug safety experience in Pharmacovigilance; premarketing safety is preferred
- Must be able to demonstrate strong knowledge of global clinical safety/Pharmacovigilance regulations, ICH guidelines and FDA/EMEA regulations regarding safety.
- Previous experience with safety databases involving query/report generation and adverse event software is highly desirable.
- Understanding of Quality Management processes and compliance monitoring
- Strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines
- Experienced in reviewing aggregate reports (ASRs, IND annual reports, and ad-hoc) for investigational products is a must.
- Project Management Skills is must.
- Strong event assessment/review/ documentation skills.
- Knowledge of MedDRA terminology and practices is a must.
- Knowledge of safety reviews process for IBs, protocols, informed consents, data and final reports.
- Knowledge of MS Word, Excel, PowerPoint and Outlook.