
PV Team Member
2 days ago
We are seeking a highly skilled Pharmacovigilance Specialist to join our team. As a PV Specialist, you will play a critical role in our pharmacovigilance efforts, handling key tasks such as data entry, initial assessments, expedited reporting evaluation, and case completion.
Your primary responsibilities will include:
- Data Entry: Accurately input data into the PV database to ensure compliance with regulatory requirements.
- Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs) to identify potential safety issues.
- Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to Health Authorities or client partners, adhering to reporting timelines.
- Reporting Preparation: Prepare standard reporting forms, including 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 to maintain data integrity.
- Quality Check: Conduct quality checks on ICSRs to detect any discrepancies or errors.
- 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.
To be successful in this role, you must possess the following skills and qualifications:
- Experience: Minimum 1 year of case processing experience.
- Software Knowledge: Proficient in ARGUS and ARISG.
- Qualification: B.Pharm, BDS, Pharm D, or M.Pharm degree.
- Communication Skills: Excellent verbal and written communication skills.
- Work Environment: Willingness to work from the office in Noida.
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