My client was founded in 1984, is a multinational pharmaceutical company headquartered in India. It is committed to providing affordable and innovative drugs for human health.

Medical oversight of trials to ensure protocol and regulatory guidelines are followed.

Interact with investigators intermittently during study conduct to understand any recruitment and medical challenges and provide suggestions.

Preparation and Review of study documents (Protocol, ICF, CRF and CSR) to ensure safety, regulatory and ethical compliance

Resolution of medical and safety related queries from sites and project team.

Training on handling of AEs/SAEs and safety reporting to study site team.

Initial safety assessment, as to whether AEs/SAEs meets definition of events that requires expedited reporting (SUSAR) and review/editing of narratives,

Provide assistance to the project manager to resolve the queries from the regulatory and/or the ethics committees.

Assist project team during SQVs and SIVs.

Continuous Medical Monitoring of trials which include eligibility assessment, general protocol questions, and safety and study investigational product related questions, review of lab reports, waiver requests, major protocol deviations/violations assessment and regular follow up of enrolled patients.

Presentation on protocol and study conduct, wherever required

Interaction with regulatory authorities.

MD with 4 - 7 years' experience in Medical monitoring.

High potential career development

Competitive salary and benefit