Role-Team Member- Pharmacovigilance (PV) – Case Processor
Role- Pharmacovigilance (PV) – Case Processor
Key skill- Understanding of the principles and concepts associated with Patient Safety case-handling process, including regulatory reporting requirements for ICSRs. Ability to prioritize, schedule and organize daily activities.
Years of experience- 1 to 5 Years
- Triage and Prioritize cases
- Full data entry of all relevant information from the source data
- Manual coding of all adverse events, medical history, concomitant medications, and laboratory values
- Complete narratives for ICSRs by checking against the information from source documents
- Workflow Monitoring activities which include Processing of reportable and non-reportable cases within applicable timelines.
- Review impacted cases daily and escalate/re-route cases to ensure follow-up processing is initiated and completed in a timely manner.
- Meet specified quality targets for case handling.
Interested candidates may apply
Please Note- Candidates who have been interviewed earlier for the said position can re-apply only after 3 months of the interview.
A Case Processor in the field of pharmacovigilance (PV) is responsible for processing adverse event reports related to drugs and medical devices. The Case Processor’s main tasks include:
- Reviewing and evaluating adverse event reports ensuring completeness and accuracy.
- Coding the adverse event reports using standard medical terminology (e.g., MedDRA)
- Performing data entry into the PV database.
- Following up with reporters to obtain missing information.
- Assisting with the preparation of periodic safety reports.
The goal of a Case Processor is to ensure that all adverse event reports are processed in a timely, accurate, and consistent manner, to support the identification of potential safety concerns and to contribute to the overall goal of ensuring the safe use of drugs and medical devices.
Required Domain Skill Set- Triage and Prioritize cases
Location of Requirement- Indore