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Senior Drug Safety Physician

2 months ago

Sahibzada Ajit Singh Nagar, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Senior Drug Safety Physician will perform medical, safety monitoring or pharmacovigilance activities for assigned projects. Senior Drug Safety Physicians will contribute to and provide medical review, analysis and guidance in all required safety reports. Senior Drug Safety Physician will act as Subject Matter Experts and supports presales activities, audits/inspection, as assigned.

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee Interacting with internal and external stakeholders for resolving issues Attending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs) Assisting the Project Lead/Functional Lead for audits and inspections Provides inputs for process improvements Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process Function as pharmacovigilance representative/safety scientist Attend/support Bid defense meetings Mentoring of Drug Safety physicians