Covid- 19 Mandatory Vaccination Requirement
Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe. Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.
- Provide strategic planning, implementation, and management of PV day to day operations activities
- Provide vendor oversight and management for all outsourced or insourced PV activities and from set up of the vendor relationships vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans) to ensuring inspection-ready documentation of oversight
- Partner with cross-functional colleagues including but not limited to Clinical Operations, Medical, Quality and clinical collaboration partners in the generation, review and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans and ensure operational implementation
- Ensure the Global Safety Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant vendors
- Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review
- Provide PV operational support to clinical trial study teams
- Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
- Serve as PV Subject Matter expert (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight, etc.
- Act as the primary PV contact within the company and across clinical collaborations
- Guide and author PV sections of protocols, IBs, CSRs and other documents including aggregate safety reports [e.g., DSURs, PSURs, etc.]
- Facilitate Safety Review Committee meetings, ensuring Signal Detection oversight to identify risks and drive resolution to identified issues
- Provide vendors with resources and training to perform their role