Plans, conducts and follows up on GxP audits of assigned entities to assess compliance with regulatory and company requirements; identify compliance risks and drive concurrence regarding their severity.
Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations through the development of Franchise documents and Standard Operating Procedures.
The experiencedPharmacovigilance/Drug Safety Senior Manager would be responsible for leadingand conducting complex process/system audits, affiliate/local operating companyaudits, and Contract/Licence Service Providers in areas such as drug safety,risk management, REMS.
In this role, you will identify, report, and implement monitoring controls and make recommendations for policies and procedures, training and/or other mechanisms to mitigate risks, or improve the effectiveness of business operations and the compliance program.
Perform project engagement responsibilities including project planning, execution and risk management, client management, subject matter expertise and guidance, project financials, and performance reviews for project team members
The Compliance Manager manages assigned compliance functions for the Company and supports the development, implementation, and maintenance of a regulatory compliance program through compliance activities across various lines of business, banking offices, and operating departments.
Execute audits and assessments of clinical investigational sites, clinical research organizations, institutional review boards, and pre-clinical sites, including ensuring the effectiveness of their quality assurance unit.