Imedglobal is Hiring Case Processors(male)
- Imedglobal Solutions
- 2 - 5 years
- Bengaluru
- 5 years ago
- Email to a friend
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Job Description
Dear Candidates,
iMED is hiring Case Processors/Quality Reviewers
Exp-2 to 5 Yrs
Job Location-JP Nagar
Notice-Immediate or 1 Month max
Should be well versed with GVP Module 6
Primary Responsibilities
Perform duplicate search, intake, triage, and attach relevant source documents in the safety database.
Perform data entry which includes causality assessment, seriousness assessment, MedDRA coding for all the events, medical history, and laboratory findings, and draft narratives.
Complete the case processing activities within the stipulated time by prioritizing allocated cases in accordance to regulatory and service level agreement timelines and contribute to management of daily workflow.
Review all follow-up information and identify relevant information and update the same in the safety database.
Conducting peer review with a check-list to ensure 100% accuracy of adverse event data by immediate review of all cases.
Ensure timely and appropriate regulatory submissions.
Identify the requirement and initiate deletions request, administrative edits, and addition of new code list terms and prepare deviation memos, to comply with guidelines and procedural documents.
Participate in continuing awareness of company procedures and guidelines to maintain regulatory compliance.
Participate in client projects, preparations for audits and inspections.
Ensure compliance with company records retention policies.
Complete all assigned trainings, both internal and client initiated within specified timelines.
Participate in Process Improvement Initiatives to keep up the Quality and Compliance score.
Ensure all activities are carried out in according to applicable control documents, and project requirement.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time
Education
Under Graduation: B.Sc in Any Specialization, BDS in Dentistry, B.Pharma in PharmacyPost Graduation: Post Graduation Not Required, MS/M.Sc(Science) in Any Specialization, M.Pharma in Pharmacy
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization
Contact Details:
Company: Imedglobal Solutions India Private LimitedLocation(s): Bengaluru
Keyskills: quality compliance case processing process improvement initiatives qc reviewer drug safety verbal communication meddra regulatory compliance pharmacovigilance quality reviewer writing skills
Imedglobal Solutions
iMEDGlobal Solutions is a leading service provider in the fields of Regulatory Affairs, Medical Affairs, Pharmacovigilance, Toxicology and Clinical Operations services to pharmaceutical, biotechnology, and medical device industries worldwide. In October 2016, iMEDGlobal merged with FMD K&L to ex...
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