As a PV Specialist, you will be integral to our pharmacovigilance efforts, handling key tasks such as:
- 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.
