Data Entry:
Accurately input data into the PV database.
Initial Assessment:
Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable.
Expedited Reporting Evaluation:
Evaluate the necessity for expedited reporting to Health Authorities or client partners, including adherence to reporting timelines.
Reporting Preparation:
Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML for submission.
Follow-Up Requests:
Prepare and send follow-up requests to obtain additional information as necessary.
ICSR Submission:
Submit ICSRs to Health Authorities and client partners, ensuring compliance with regulatory requirements.
Case Completion:
Ensure thorough documentation and completion of cases.
Quality Check:
Conduct quality checks on ICSRs to maintain data integrity.
Search/Retrieval:
Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources.
Case Management:
Allocate and manage cases effectively within the team.
Training:
Provide training on the system to team members to enhance their operational capabilities.
Additional Responsibilities:
Undertake other tasks as assigned by the Management team.

Your Profile:

Experience:
Minimum 1 year of case processing experience.
Software Knowledge:
Proficient in ARGUS and ARISG.
Qualification:
B.Pharm, BDS, Pharm D, or M.Pharm.
Communication Skills:
Excellent verbal and written communication skills.
Work Environment:
Willingness to work from the office in Noida.

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