Drug safety associate provides advice to case processing team in data entry of clinical trial safety database and to medical coding of adverse events and diseases according.
Drug Safety Associate Duties & Responsibilities
To 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 Lead
Determining 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 guidelines
Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance
Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines
Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements
Perform post surveillance activities such as literature review and media monitoring
Reconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs
Responsible for keeping drug safety databases up to date
Keyskills: drug regulatory affairs translational medicine pharmaceutical medicine drug development drug safety drug monitoring drug accountability medical affairs
JAI AMBEY EMERGENCY SERVICES (I) PRIVATE LIMITED (JAES) was founded about a decade ago and subsequently is incorporated on the 11th of June 2015 under the Companies Act of 2013 to provide, maintain, hire, undertake and run Emergency Services.With the aim of providing all kinds of fast servic...