JAI AMBEY EMERGENCY SERVICES (I) PRIVATE LIMITED Looking for Drug Safety Associate

JAI AMBEY EMERGENCY SERVICES (I) PRIVATE LIMITED; London; On-site; INR 200,000 - 500,000; Full time

Job summary

Join a forward-thinking healthcare organization as a Drug Safety Associate, where you will play a crucial role in managing clinical trial data and ensuring regulatory compliance. This position involves advising the case processing team, managing adverse events, and maintaining the safety database to uphold high standards in drug safety. You will be part of a dynamic team dedicated to improving patient safety and healthcare outcomes. If you are passionate about making a difference in the healthcare sector, this is the opportunity for you!

Qualifications

• Experience in data entry of clinical trial SAEs and medical coding.
• Knowledge of regulatory requirements and drug safety practices.

Responsibilities

• Identify and manage adverse events according to SOPs.
• Capture data accurately in the safety database and ensure compliance.
• Support the Drug Safety Team in maintaining high standards.

Skills

Data Entry

Clinical Trial Knowledge

Medical Coding

Regulatory Compliance

Tools

Argus Safety Database

Job description

Job Location: Vishakhapatnam, Chennai, Kochi, Kolkata, Silchar, Tawang, Panna, Other Bihar, Other Karnataka, Ahmedabad

Education: Not Mentioned

Salary: Rs 2.0 – 5 Lakh/Yr

Industry: Medical / Healthcare

Functional Area: Medical Transcription, Pharmacist / Medical Representative

Employment Type: Full-time

Job Description

Drug safety associate provides advice to the case processing team in data entry of clinical trial SAEs into the Argus safety database and to medical coding of adverse events and diseases according to MedDRA terminology.

Duties & Responsibilities

1. Identify out of scope activities in conjunction with the MSS Functional Lead.
2. Determine 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 handle it accordingly per the relevant SOPs and guidelines.
3. Reconcile activities with all data sources providing safety information – Specialty Pharmacies, Business Partners, and Internal Stakeholders to ensure compliance.
4. 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.
5. Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements.
6. Perform post surveillance activities such as literature review and media monitoring.
7. Reconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries, and MAPs.
8. Responsible for keeping drug safety databases up to date.
9. Support the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identified.
10. Act as record management coordinator for the Drug Safety Team.