- 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.
- M Pharmacy or Pharm D.
- Minimum of 10 years of experience in Pharmacovigilance (PV) Safety.
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ICSRs Project Lead - Hyderabad / Secunderabad, Telangana - Thepharmadaily
Description
Key Responsibilities:
Education and Experience:
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IT Project Lead
Full time Medtronic- Hyderabad / Secunderabad, Telangana
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IT Project Lead
Full time Medtronic- Hyderabad / Secunderabad, Telangana
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Project Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
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QA Project lead
Full time Adecco India Private Limited- Hyderabad / Secunderabad, Telangana
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It Project Manager Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
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ICSRs Project Lead
Full time Thepharmadaily- Hyderabad / Secunderabad, Telangana
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Civil Projects Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
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Lead Safety – Projects
Full time Adani Group- Hyderabad / Secunderabad, Telangana
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Civil Projects Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
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Assistant project lead
Full time Jones Lang Lasalle Property Consultants- Hyderabad / Secunderabad, Telangana
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Business Project Lead Analyst
Full time Cigna Medical Group- Hyderabad / Secunderabad, Telangana
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Strategy Project Management Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
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Integrated Project Team Lead
Full time Cyient Inc- Hyderabad / Secunderabad, Telangana
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Project Manager/ Lead MEP
Full time Jones Lang Lasalle Property Consultants- Hyderabad / Secunderabad, Telangana
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HIH - IT Project Management Lead Analyst - Evernorth
Full time Cigna Medical Group- Hyderabad / Secunderabad, Telangana
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Senior IT Project Lead-T GOSC Manufacturing Systems Digitalization
Full time Medtronic- Hyderabad / Secunderabad, Telangana
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Big data Lead
Full time confidential- Hyderabad / Secunderabad, Telangana
-
IT delivery manager
Full time confidential- Hyderabad / Secunderabad, Telangana
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Project Manager
Full time Apollo Telehealth- Hyderabad / Secunderabad, Telangana
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Senior Delivery Manager
Full time confidential- Hyderabad / Secunderabad, Telangana
