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
The Drug Safety Associate provides advice to the case processing team in data entry of clinical trial Serious Adverse Events (SAEs) into the Argus safety database and to medical coding of adverse events and diseases according to MedDRA terminology.
Duties & Responsibilities
- Identify out of scope activities in conjunction with the MSS Functional Lead.
- 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.
- Conduct 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.
- Keep drug safety databases up to date.
- Support the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identified.
- Act as record management coordinator for the Drug Safety Team.
#J-18808-Ljbffr
