Drug Safety Specialist Job

Drug Safety Specialist is needed to perform the following duties :

o Assist with the receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences received by Pharmacovigilance Safety Database. Triage events for expectedness and reportability along with the Contract Research Organization (CRO)
o Review adverse drug experience reports entered into the Safety Database.
o 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.
o Completing AE/SAE reconciliation prior to clinical trial database closure
o Assist with submission of expedited reports to Health Authorities globally. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreements (SDEA) with business partners. Manage expedited submission history in safety database and tracks reporting compliance with regulations.
o Determine labelled/expectedness of reported events, writing narratives and performing quality checks prior to medical review.
o Contribute to the timely preparation of ad-hoc and aggregate reports, including Developmental Safety Update Reports (DSURs), 6-monthly SUSAR Line-Listing Reports, IND annual reports, liaising with managers, physicians, and Pharmacovigilance colleagues as appropriate; and Prepare and maintain internal filing systems, archive safety files and scan source information for archival in electronic systems.
o Review of vendor case deactivation requests to ensure AE data is has been completed correctly, case merges are complete and correct and that the request is valid.
o Push valid requests for business approval or reject and communicate issues/request corrections from vendor.
o Collaborate with internal departments to support and develop standard operating procedures/working practices/collection forms and adhere to company and departmental SOPs as required.
o Writing required narrative texts for medical orientation.
o Assessing, processing and entering key data around adverse event case type.
o Proactively supporting inspections and audits with regulatory affairs groups.
o Identify potential 7-Day and 15-Day Alerts and Report endpoints to FDA or other regulatory authorities and ethics committees within specified timelines.
o Supports the management of case processing deadlines for aggregate safety reporting.

Bachelor’s Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Science