ICSRs Project Lead

3 weeks ago

Hyderabad, Telangana, India Thepharmadaily Full time
Job Description

Key Responsibilities:

- Perform as the ICSRs Project Lead for assigned pharmacovigilance projects.
- Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials.
- Maintain knowledge of client-specific database conventions.
- Collaborate with internal or external partners for safety database reconciliation.
- Monitor workflow for assigned studies or programs to meet deadlines.
- Draft, modify, and deliver safety presentations to both external and internal stakeholders.
- Assist in developing departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
- Ensure ICSR regulatory submissions are compliant with both US and international regulatory reporting requirements.
- Understand the scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
- Experience in case processing using Argus and handling various types of cases (solicited, literature, spontaneous).
- Generate monthly status reports and other project-specific reports, ensuring data quality and accuracy.
- Conduct quality checks on case data and finalize case versions.
- Manage case follow-ups, including generating queries and clarifications as needed.
- Handle case amendments or deletions and investigate late cases to propose corrective and preventive actions.
- Support data reconciliation, replenishment, and clean-up activities.
- Assist with safety database updates and data migration projects.
- Identify, investigate, and resolve process or training issues, creating corrective/preventive actions (CAPAs) as necessary.
- Participate actively in project team and client meetings, and liaise with clients as appropriate.
- Prepare for and participate in internal, client, or regulatory audits, and support other functional safety leads in audit preparation.

Education and Experience:

- M Pharmacy or Pharm D.
- Minimum of 10 years of experience in Pharmacovigilance (PV) Safety.

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