Akshay Shingate

Business Process Lead – BPO Department Lead and oversee end-to-end business processes within the BPO, ensuring accuracy and compliance in pharmacovigilance activities. Key responsibilities include performing initial adverse event form checks, duplicate searches, and case initiation in safety databases with meticulous tracking. Liaise effectively with clients to resolve discrepancies, assess event expectedness using labeling documents, and identify potential SUSARs. Utilize MedDRA for precise medical coding and draft comprehensive case narratives. Coordinate with Safety Responsible personnel to address information gaps and actively participate in PVQ audits to maintain quality standards.

Processing both serious and non-serious Individual Case Safety Reports (ICSRs) involves assessing validity and ensuring consistent quality throughout. This includes performing quality checks for MedDRA coding of events, medical history, and patient history. Additionally, maintaining the safety database and following entry guidelines accurately is crucial. Quality control processes are employed to ensure data quality, while mentorship and workflow management are conducted.