Desmond Ongaria Okia

Manager, Worldwide Safety & Regulatory Quality Control @辉瑞

Peapack - Gladstone, NJ, US

Provide project management and leadership to drive effective delivery of Health Authority obligations/agreements, serving as a conduit between Safety/PV SMEs, business lines, Regulatory groups, and governance groups.• Review Data Collection Aids (DCA) and questionnaires for Adverse Event (AE) follow-up, required by Health Authorities for certain Product-AE combinations. Work with Drug Safety Units to ensure clear explanations exist where DCA’s have not been used.• Lead or support the aggregation, trending, and analysis of various metric data, plus lead or facilitate the discussion of metrics, trends, delay reasons.• Develop KPI dashboards, reports, and tools to track timeliness/compliance of deliverables.• Review Pharmacovigilance/Regulatory product source data and disseminate, input, track and close out agreements/obligations made on behalf of PV/Safety.• Prepare and respond to Regulatory Agency Inspections as well as internal and external audits• Review change control processes/procedures, and contribute to evolution of various metrics processes. Suggest improvements to the process, identify risks to the process and help to ensure that quality is built-in to enable consistent performance.• Contribute to the development and implementation of strategies for compliance, performance, process analytics, information delivery and corrective action implementation.• Provide input on quality services and policies collaborating with Directors and Senior Directors.• Maintain current knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidelines.

Jamia Hamdard UIniversity, New Delhi, India

Bachelor of Pharmacy (B.Pharm.)

London School of Hygiene and Tropical Medicine, U. of London

MSc Public Health