Drug Safety Associate

Job Description

Drug safety associate provides advice to case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases according to MedDRA terminology. Drug Safety Associate Duties & ResponsibilitiesTo write an effective drug safety associate job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety associate job description templates that you can modify and use.Sample responsibilities for this position include:Identify out of scope activities in conjunction with the MSS Functional LeadDetermining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelinesReconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure complianceManage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelinesAccurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirementsPerform post surveillance activities such as literature review and media monitoringReconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPsResponsible for keeping drug safety databases up to dateSupport the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identifiedAct as record management coordinator for the Drug Safety Team

Keyskills :
pharmaceutical medicinemedical affairsclinical trialsdrug safetydrug accountabilitydrug regulatory affairsdrug monitoring