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ICSRs Project Lead - Pharmacovigilance

ConfidentialHyderabad / Secunderabad, Telangana

9 days ago

Job description

Project Leadership : Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).

Adverse Event Management : Oversee the receipt and processing of all adverse event reports from various sources, including spontaneous reports and clinical trials, for assigned projects.

Database Management : Maintain a thorough understanding of client-specific database conventions and support reconciliation with internal or external partners as needed.

Workflow Monitoring : Support workflow monitoring to ensure project deadlines are met.

Safety Presentations : Draft, modify, and deliver safety presentations to both external and internal stakeholders.

SOP and WI Development : Assist in creating and updating departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).

Regulatory Compliance : Ensure compliance with ICSR regulatory submission requirements according to US and international regulations, SOPs, and safety processing guidelines.

Scheduling Reports : Manage automated and manual scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.

Case Processing : Handle case processing in Argus, including solicited, literature, and spontaneous cases.

Reporting : Generate monthly status and project-specific reports, ensuring the quality and accuracy of metrics and data.

Quality Checks : Perform quality checks on case data and finalize case versions.

Follow-Up and Amendments : Conduct case follow-ups, generate queries and clarifications, and perform case amendments or deletions as needed.

Investigation and CAPAs : Conduct late case investigations, propose corrective and preventive actions (CAPAs), and support process / training remediation.

Data Clean-Up : Support reconciliation, replenishment, and data clean-up activities.

Safety Database Updates : Assist with safety database updates and data migration activities.

Process Improvement : Investigate and address process or training issues, facilitating the creation of CAPAs and supporting remediation efforts.

Client and Team Liaison : Actively participate in project team and client meetings, liaise with clients as appropriate, and prepare for internal, client, or regulatory audits.

Education and Experience :

Master s Degree in Pharmacy (M.Pharm) or Doctor of Pharmacy (Pharm D).
Minimum of 10 years of experience in pharmacovigilance and safety.

Skills Required

capas , Sops

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Project Lead • Hyderabad / Secunderabad, Telangana

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