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0.0 - 4.0 years
0 Lacs
nagpur, maharashtra
On-site
As a Safety Specialist, your primary responsibility will be to receive, triage, and process individual case safety reports (ICSRs) in a timely manner. You will accurately enter event data into PV databases and code medical terms using MedDRA / WHO-DD codes. It will be your duty to assess the seriousness, causality, and expectedness of cases, as well as conduct literature surveillance to identify potential safety signals. Additionally, you will play a key role in assisting with the preparation of case narratives, reports, and documentation. You will support the creation of aggregate safety reports such as PSURs and RMPs. Ensuring strict adherence to SOPs and regulatory standards will be cruci...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
You will be working as a Clinical Data Coder 1 with a focus on MedDRA and WHODD coding. With 2-5 years of work experience, the role is based in Bangalore and requires office-based work. Your key skills will include expertise in MedDRA, WHODD, clinical data coding, and clinical coding. As a Clinical Data Coder, you will provide essential data management support to the Data Management team to meet sponsor and company requirements effectively. You will be responsible for Clinical Data Management and/or Coding activities, potentially leading as a Lead Coder or Data Operations Coordinator for specific tasks on mega trials. Your main responsibilities will include managing coding activities and pro...
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Clinical Data Coder 1 specializing in MedDRA and WHODD, with 2-5 years of work experience, your primary responsibility will be to provide comprehensive data management expertise to the Data Management (DM) team for meeting sponsor and company needs. You will be involved in performing Clinical Data Management and/or Coding activities, taking on leadership roles such as Lead Coder or Data Operations Coordinator (DOC) for specific CDM tasks, or leading coding tasks on mega trials. In this role, you will independently manage coding activities and projects throughout the full study life-cycle, ensuring high quality and timely delivery with minimal guidance. Your responsibilities will include...
Posted 2 months ago
2.0 - 5.0 years
3 - 8 Lacs
Thane, Bengaluru
Hybrid
Job Title / Primary Skill: Clinical data coder Years of Experience: 2-5 Years Job Location: Bangalore/Thane Must Have Skills: Clinical coding, MedDRA, WHODD, Clinical data management Good To Have Skills: Rave, Job Description Provide comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership either in the role of the Lead Coder or in a specific CDM task (e.g. Data Operations Coordinator (DOC) or lead a coding related task on a mega trial). In-depth knowledge of medical dictionaries used for coding (e.g.,...
Posted 4 months ago
3.0 - 5.0 years
4 - 7 Lacs
vadodara, manjusar
Work from Office
Department - Clinical Roles and Responsibilities: End to End clinical data management and pertinent documentation for clinical studies and real-world data collection. Managing vendors for CDM Conducting User Acceptance Testing Provide guidance on training requirements in relation data management System and technical Skills Regulations and Standards 21CFR part 11, GDPR, ISO 27001, SDLC and ISO 62304, CDISC standards Databases & ORM: EDC databases - Clinion, OCRDC, Oracle one, Inform, Open clinica, etc. MS Access Tools: MS office, Power Automate, Power BI, MedDRA, WHODD, Rave, Clinion, Research Manager Understanding of the Medical Device industry
Posted Date not available
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